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

Catalog Number	1101-03516F
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/23/2016
Type of Reportable Event	Malfunction
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.Damage to the outer collet is consistent with instrument misalignment.The reported "squeaking" noise could not be recreated with a sampling of screws from stock.While none of the implants were returned, a general review of the manufacturing and inspection records revealed no additional information.In situ.
Event or Problem Description
On (b)(6) 2016 it was reported to k2m, inc.That during a surgery a screw was damaged during locking and remains in the patient.It was also reported that each of the screws in the construct were squeaking during the locking process.

• Brand Name: CASPIAN SPINAL SYSTEM
• Common Device Name: SPINAL FIXATION SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 6200227
• Report Number: 3004774118-2016-00106
• Device Sequence Number: 509697
• Product Code: NKG
• UDI-Device Identifier: 10888857012455
• UDI-Public: 10888857012455
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2016

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: 1101-03516F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2016
• Initial Report FDA Received Date: 12/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1