Devices

QS, MDR Violations at Globus Medical

David McFarland

— 1 min read
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A 2/15-3/7 FDA inspection at Globus Medical, Inc., in Audubon, PA, found Quality System (QS) and Medical Device Reporting (MDR) violations associated with the firm’s manufacturing of the Class 2 Excelsius GPS surgical robot and associated interbody spine and cranial modules. A just-released 7/15 Warning Letter says specific QS regulation violations were:

  • failure to establish and maintain procedures for implementing corrective and preventive actions, including requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned products, and other sources of quality data to identify existing and potential causes of nonconforming products, or other quality problems using appropriate statistical methodology; and
  • failure to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications.

FDA says the firm’s responses to the two QS observations were inadequate. The specific MDR violations were:

  • failure to submit a report to FDA no later than 30 calendar days after the day the firm received or otherwise became aware of information, from any source, that reasonably suggested that a device it markets may have caused or contributed to a death or serious injury;
  • failure to submit a report to FDA no later than 30 calendar days after the day the firm received or otherwise became aware of information, from any source, that reasonably suggested that a device it markets has malfunctioned and that the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; and
  • failure to maintain copies of all electronic acknowledgments FDA sends the company in response to electronic MDR submissions in the MDR event file.

FDA says Globus’ responses to these observations were inadequate or their adequacy could not be determined.

Globus was told to take prompt action to address the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the steps, and a schedule for completing the corrections.

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