MAUDE Adverse Event Report: K2M, INC. CASPIAN OCT SPINAL SYSTEM; SPINAL FIXATION SYSTEM

Catalog Number	1101-10001
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Fall (1848); No Information (3190)
Date of Event	06/14/2016
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 no lot number has been identified/confirmed in this case.Since the set screw remains in the patient no physical, material, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.A general review of the manufacturing and inspection records did not reveal any contributing information/trends.During the revision, it was observed that the set screw and nut of the connector were loose.The implants were re-tightened during the revision.No definitive root cause can be determined.Device remains in patient.
Event or Problem Description
It was reported to k2m, inc.On 6/1/2016 that implants had loosened in an occipital bolt case post-op.Patient was revised on (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 no lot number has been identified/confirmed in this case.Since the set screw was not returned, no physical, material, chemical evaluation could be performed, and the exact cause of the reported issue could not be ascertained.A general review of the manufacturing and inspection records did not reveal any contributing information/trends.Device remains in patient.
Event or Problem Description
It was reported to k2m, inc.On 6/1/2016 that implants had loosened in an occipital bolt case post-op.Patient was revised on (b)(6) 2016.Patient had a fall and was revised again on (b)(6) 2016.

• Brand Name: CASPIAN OCT SPINAL SYSTEM
• Common Device Name: SPINAL FIXATION SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 5756195
• Report Number: 3004774118-2016-00053
• Device Sequence Number: 542213
• Product Code: NKG
• UDI-Device Identifier: 10888857015593
• UDI-Public: 10888857015593
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153370
• 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): 06/01/2016

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: 1101-10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2016
• Supplement Report FDA Received Date: 08/09/2016
• 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: 53 YR