MAUDE Adverse Event Report: K2M, INC. PYRENEES CERVICAL PLATE SYSTEM; ANTERIOR CERVICAL PLATE

Catalog Number	208-44F69
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.In situ.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a possible plate fracture.The patient reportedly had possible plate fracture approximately 6 months post-op.There are no plans to revise at this time.
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case.Since the screw remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.All of the screws appeared to be locked to the plate.The difference in the orientation of the screws and interbodies in the pre and post-incident x-rays indicates that there was some movement in the construct, which may have contributed to this incident via increased bending stress on the plate.It was also reported that there are signs of fusion, but there were no reports of a solid fusion; therefore, a potential pseudarthrosis may have also contributed to this incident.In situ.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a possible plate fracture.The patient reportedly had possible plate fracture approximately 6 months post-op.There are no plans to revise at this time.

• Brand Name: PYRENEES CERVICAL PLATE SYSTEM
• Common Device Name: ANTERIOR CERVICAL PLATE
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6604028
• Report Number: 3004774118-2017-00059
• Device Sequence Number: 558019
• Product Code: KWQ
• UDI-Device Identifier: 10888857031364
• UDI-Public: 10888857031364
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 208-44F69
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1