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

Catalog Number	5901-14512D
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Tingling (2171)
Date of Event	09/14/2016
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.Not returned.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That the superior and inferior screws are starting to back our of a mono plate approximately 6 months post-op.
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 screw remains in the patient, no physical, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.A review of the x-rays from the case show that the superior and inferior screws were inserted to 25 degree and 26 degree respectively, which is well beyond the maximum specified angle of 15 degree for tifix.Consequently, the amount of tifix threads in contact with the plate is lower, resulting in an insufficient lock, thereby causing the screws to back out.The superior screw also appeared to be in contact with the superior peek interbody, which may have also contributed to this incident, as the resistance supplied by the interbody could have caused the torque handle to torque off before the screw was locked.While none of the implants were returned, a general review of the manufacturing and inspection records revealed no additional information.Not returned.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That the superior and inferior screws are starting to back out of a mono plate approximately 6 months post-op.

• 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: 6025397
• Report Number: 3004774118-2016-00079
• Device Sequence Number: 1168208
• Product Code: KWQ
• UDI-Device Identifier: 10888857112803
• UDI-Public: 10888857112803
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150983
• 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): 09/14/2016

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: 5901-14512D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2016
• Supplement Report FDA Received Date: 11/11/2016
• 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: (B)(4), LOT UNKNOWN; (B)(4), LOT UNKNOWN
• Patient Age: 58 YR