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

Catalog Number	811-H655495
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/05/2016
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.Remains in patient.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That a patient had a broken rod approximately 21 months post-op.No revision surgery has taken place 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 rail remains in the patient, no physical, chemical evaluation could be performed, and the exact 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.Remains in patient.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That a patient had a broken rod approximately 21 months post-op.No revision surgery has taken place at this time.

• Brand Name: MESA SPINAL SYSTEM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6078413
• Report Number: 3004774118-2016-00085
• Device Sequence Number: 13745359
• Product Code: NKB
• UDI-Device Identifier: 10888857144699
• UDI-Public: 10888857144699
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2016

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: 811-H655495
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2016
• Supplement Report FDA Received Date: 11/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1