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

Catalog Number	201-14014D
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/08/2017
Type of Reportable Event	Serious Injury
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.The proximal interbody appeared to have settled into the inferior vertebra (c6), indicating movement in the construct, which may have contributed to this incident by imparting more stress on the distal screws.The patient also reportedly has a history of smoking, which is listed as a contraindication in our instructions for use (ifu) due to its negative effect on bone quality and bony union.In situ.
Event or Problem Description
On (b)(6)2017 it was reported to k2m, inc.That a patient presented with a possible cervical screw back-out.The patient reportedly had a possible cervical screw back-out approximately 2 weeks post-op.There are no plans to revise at this time.
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 was disposed, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.The proximal interbody appeared to have settled into the inferior vertebra (c6), indicating movement in the construct, which may have contributed to this incident by imparting more stress on the distal screws.The patient also reportedly has a history of smoking, which is listed as a contraindication in our instructions for use (ifu) due to its negative effect on bone quality and bony union.
Event or Problem Description
On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a possible cervical screw back-out.The patient reportedly had a possible cervical screw back-out approximately 2 weeks post-op.The patient was not revised.On (b)(6) 2017 k2m, inc.Was notified that the patient was revised due to the risk of the screw possibly backing-out further.

• 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: 6688888
• Report Number: 3004774118-2017-00082
• Device Sequence Number: 57658
• Product Code: KWQ
• UDI-Device Identifier: 10888857026995
• UDI-Public: 10888857026995
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K0643544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Catalogue Number: 201-14014D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 09/22/2017
• 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: 208-42F40 LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention