MAUDE Adverse Event Report: K2M, INC. PYRENEES CERVICAL PLATE SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	208-43F60
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
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 plate remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.It was reported to manufacturer at six months post-op and recent follow-up based on x-rays and physical exam that the patient showed evidence of solid fusion.The surgeon also noted that a cage was located anterior towards the plate position and possibly transferred undue stresses to the plate.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 approximately 2 years post-op with a fractured plate.There are no plans to revise at this time.

• Brand Name: PYRENEES CERVICAL PLATE SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6446445
• Report Number: 3004774118-2017-00019
• Device Sequence Number: 10878161
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2017

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: 208-43F60
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/30/2017
• 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: 201-14014D LOT UNKNOWN; 201-14316C LOT UNKNOWN