MAUDE Adverse Event Report: K2M, INC. MESA SPINAL SYSTEM; PEDICLE SCREW SYSTEM

Catalog Number	801-35540M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/05/2016
Type of Reportable Event	Serious Injury
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 a revision surgery took place in which a fractured screw was removed.The patient reportedly had a fractured screw approximately 12 months post-op.Revision surgery took place (b)(6) 2016.
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.It was confirmed via x-ray that a mesa screw fractured post-operatively.There was a reported non-union, which may have contributed to the incident.However, the root cause of the reported issue could not be ascertained.While none of the implants were returned, a general review of the manufacturing and inspection records revealed no additional information.Patient retained.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That a revision surgery took place in which a fractured screw was removed.The patient reportedly had a fractured screw approximately 12 months post-op.Revision surgery took place (b)(6) 2016.

• Brand Name: MESA SPINAL SYSTEM
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6200135
• Report Number: 3004774118-2016-00108
• Device Sequence Number: 377324
• Product Code: NKB
• UDI-Device Identifier: 10888857139879
• UDI-Public: 10888857139879
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2016

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?: No
• Operator of Device: Physician
• Device Catalogue Number: 801-35540M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 01/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Weight: 52