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

Catalog Number	201-14014C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/10/2017
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 is complete, k2m inc.Will file a supplemental report indicating the findings.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a broken self-tapping screw.The patient reportedly had an self-tapping screw break approximately 4 months post-op.There has been no revision 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.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.X-rays were reviewed however, the quality of the fluoro made it difficult to see the construct clearly and did not contribute any additional information.
Event or Problem Description
On 2/10/2017 it was reported to k2m, inc.That a patient presented with a broken self-tapping screw.The patient reportedly had an self-tapping screw break approximately 4 months post-op.There has been no revision to date.

• Brand Name: PYRENEES CERVICAL PLATE SYSTEM
• Common Device Name: ANTERIOR CEREVICAL PLATE
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6383646
• Report Number: 3004774118-2017-00011
• Device Sequence Number: 19001140
• 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,Followup
• Report Date (Section B): 02/10/2017

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: 201-14014C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1