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

Catalog Number 5808-21540L10

Device Problem Collapse (1099)

Patient Problem No Information (3190)

Event Date 11/22/2016

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 exact cause of the reported issue could not be ascertained.Looking at the position of the movable paw in one of the post-op images, it did not appear that the implant was fully locked.The space between the draw screw and the tooth assembly appeared to be larger in the immediate post-op images, indicating that the teeth were not fully engaged.However, this was difficult to confirm because the x-rays were taken in different planes and were not high-resolution images.While we cannot definitively say that this was the direct or only cause, it is possible that the inserter/expander was not fully withdrawn prior to tightening the draw screw.If the wedge was not fully removed, the teeth could have been misaligned, which may have resulted in an insufficient lock, therefore making it much easier to collapse the cage.Based on the information provided it is difficult for us to identify any other potential causes at this time.While none of the products were returned, a general review of the manufacturing and inspection records revealed no additional information.Remains in patient.

Event Description

On (b)(6) 2016 it was reported to k2m, inc.That a patient presented with a possible expandable alif collapse.The patient reportedly had an expandable alif collapse approximately 1 ½ months post-op.There are no plans to revise at this time as the patient is asymptomatic.

• Brand Name: SAHARA STABILIZATION 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: 6194770
• MDR Text Key: 63068122
• Report Number: 3004774118-2016-00102
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 10888857213357
• UDI-Public: 10888857213357
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 5808-21540L10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2016
• 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