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

Catalog Number	201-14014C
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/08/2016
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 screw remains in the patient, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.Review of an x-ray showed the screw backed out at the distal end of the construct.The intra-op ct provided was blurry which made it difficult to determine whether or not the screw was locked to the plate.The angle of the screw appeared to be within the specified angle of tifix, and the surgeon reportedly used the torque handle to lock all of the screws.No root cause could be determined with the information provided and without being able to evaluate the implants for signs of locking.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 possible pyrenees screw back-out.The patient reportedly had an pyrenees screw back-out approximately 1 ½ 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 SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6215914
• Report Number: 3004774118-2016-00113
• Device Sequence Number: 11040520
• Product Code: KWQ
• UDI-Device Identifier: 10888857026988
• UDI-Public: 10888857026988
• 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): 12/08/2016

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: 201-14014C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 12/30/2016
• 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: 208-43F48 LOT UNKNOWN