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

Catalog Number 1101-03516F

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/23/2016

Event Type  malfunction  

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 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
• Type of Device: SPINAL FIXATION SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: sandra gilbert ; 600 hope parkway se; leesburg, VA 20175 ; 5719192000
• MDR Report Key: 6200227
• MDR Text Key: 63211523
• Report Number: 3004774118-2016-00106
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10888857012455
• UDI-Public: 10888857012455
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Physician
• Device Catalogue Number: 1101-03516F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1