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

Catalog Number	208-42F40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 plate remains in the patient, no physical, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.It was reported to manufacturer that the patient was elderly, diagnosed with osteoporosis, and had a history of smoking and cancer.The patient also suffered a pseudarthrosis, thereby forcing the plate to take all of the load of the construct, likely resulting in the plate fracturing.While none of the implants were returned, a general review of the manufacturing and inspection records revealed no additional information.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That a plate fractured.The patient reportedly had a fractured plate approximately 18 months post-op.There are no plans to revise the patient at this time.

• Brand Name: PYRENEES CERVICAL PLATE SYSTEM
• Common Device Name: ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6134359
• Report Number: 3004774118-2016-00093
• Device Sequence Number: 153536
• Product Code: KWQ
• UDI-Device Identifier: 10888857030954
• UDI-Public: 10888857030954
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2016

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: 208-42F40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 11/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 201-14014C LOT UNKNOWN
• Patient Age: 61 YR