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

Catalog Number	208-43F57
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/17/2017
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 of the subject part 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 fractured 3 level plate.The patient reportedly had a fractured 3 level plate approximately 5 months post-op.There has been no revision surgery to date.
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.The fracture occurred through the plate's screw holes (second row of screw holes from the bottom of the construct), which is where plates typically fracture due to the reduction in cross-sectional area.The x-ray was also analyzed for any signs of fusion/non-union, but no determinations could be made due to the quality of the x-ray.In closing, no root causes could be determined, as the plate was left in the patient and could not be analyzed, and no conclusions could be drawn from the provided x-ray.The complexity of the case, however, may have contributed to this incident, as the plate fractured just below the corpectomy cage.While none of the implants were returned, a general review of the manufacturing and inspection records revealed no additional information.In situ.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a fractured 3 level plate.The patient reportedly had a fractured 3 level plate approximately 5 months post-op.There has been no revision surgery to date.

• 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: 6326962
• Report Number: 3004774118-2017-00003
• Device Sequence Number: 13707215
• Product Code: KWQ
• UDI-Device Identifier: 10888857031166
• UDI-Public: 10888857031166
• 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): 01/17/2017

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: 208-43F57
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 03/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1