MAUDE Adverse Event Report: K2M, INC. SAHARA STABILIZATION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 5808-21436L10

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 05/12/2017

Event Type  malfunction  

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.In situ.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a possible expandable alif cage collapse.The patient reportedly had a possible cage collapse approximately 3 months post-op.There are no plans to revise at this time.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.Based on x-rays, 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cannot definitively say that this was the direct or only cause, it is possible that the inserter/expander was not fully withdrawn prior to tightening the draw screw.If the wedge was not fully removed, the teeth could have been misaligned, which may have resulted in an insufficient lock,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.The root cause of the reported issue could not be ascertained.In situ.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a possible expandable alif cage collapse.The patient reportedly had a possible cage collapse approximately 3 months post-op.There are no plans to revise at this time.

• Brand Name: SAHARA STABILIZATION SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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 ; 5719195195
• MDR Report Key: 6632467
• MDR Text Key: 77505221
• Report Number: 3004774118-2017-00071
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 10888857213272
• UDI-Public: 10888857213272
• 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,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 5808-21436L10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2017
• 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