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

Catalog Number	208-43F54
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/13/2016
Type of Reportable Event	Serious Injury
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.A review of the x-ray confirmed the plate fractured through the screw holes.Review of the x-ray also shows, the patient does not appear have fused, thereby placing more stress on the bottom of the plate, likely contributing to the failure.While none of the implants were returned, a general review of the manufacturing and inspection records revealed no additional information.Insitu.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That a patient presented with a broken 3 level plate.The patient reportedly had a 3 level plate break approximately 7 months post-op.There are no plans to revise at this time as the patient is asymptomatic.

• 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: 6246271
• Report Number: 3004774118-2016-00115
• Device Sequence Number: 16249748
• Product Code: KWQ
• UDI-Device Identifier: 10888857031159
• UDI-Public: 10888857031159
• 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
• Report Date (Section B): 12/13/2016

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: 208-43F54
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2016
• Initial Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR