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

Catalog Number	208-43F60
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The investigation is still in progress.Upon completion of the investigation, k2m inc.Will file a supplemental report indicating the findings.Device remains in patient.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That a three level plate fractured.There are no plans to revise.The patient reportedly had a fractured plate approximately 4-6 months post-op.
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 no lot number has been identified/confirmed in this case.Since the plate remains in the patient, no physical, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.As seen in the x-ray, the c6-7 disc space is starting to collapse; the bone graft between the c6 and c7 vertebral bodies is noticeably shorter in height than that of the c4-5 and c5-6 bone grafts.The collapse of the c6-7 disc space also likely imparted more stress on the plate, thereby contributing to the fracture, which occurred at the same location as the collapsed disc space.A general review of the manufacturing and inspection records did not reveal any contributing information.Device remains in patient.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That a three level plate fractured.There are no plans to revise.The patient reportedly had a fractured plate approximately 4-6 months post-op.
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.The plate fractured through the screw holes.The patient appears to have fused only at c6-7 thus creating a lever arm about the fused level, thereby placing more stress on the bottom of the plate.The analysis indicated an overloading event, not a fatigue failure which is consistent with how the patient fused.Our investigation of the product and review of the manufacturing and inspection records revealed no manufacturing discrepancies or material defects, nor did it reveal any contributing information/trends.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That a revision surgery took place in which a fractured three level plate was removed.The revision surgery took place on (b)(6) 2016.

• 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: 5943723
• Report Number: 3004774118-2016-00069
• Device Sequence Number: 722244
• Product Code: KWQ
• UDI-Device Identifier: 10888857031173
• UDI-Public: 10888857031173
• 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
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 208-43F60
• Device Lot Number: DXDB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/16/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/12/2016
• Supplement Report FDA Received Date: 10/05/2016; 11/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention