MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS UNILIF SPACER 10 X 30 X 0DEG - 11MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48351100

Device Problems Device Slipped (1584); Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 10/14/2016

Event Type  Injury  

Event Description

It was reported that; on (b)(6) 2015, the patient underwent a 6-level spinal fusion (t10-l3) and a 3-level revision (l4-s1).The surgeon performed the surgery using products.Approximately 3 months after the surgery, the double-lock screw caps began to fail, causing the screws at l1-l2 to back out of place and the hardware to fall out of alignment.On (b)(6) 2016, the surgeon operated to replace the defective hardware and used triple-lock screw caps to secure the new hardware.My son continued to have constant pain and mobility problems.Further ct scans revealed the double-lock screw caps, from the december surgery, at l4-s1 had failed.This hardware failure caused the screws to back out of place and the hardware to fall out of alignment.In addition, some of these screws were holding a rod in place.Without the screws holding it in place, the rod was literally banging around the base of the spine.On (b)(6) 2016, the surgeon replaced all the defective hardware, replaced the rod which was now damaged, and used the triple-lock screw caps to hold everything in place.These two surgeries caused the patient extreme pain, all because of hardware failures.

Manufacturer Narrative

Catalog# 48351100.Method: risk assessment: results: device history, device evaluation, complaint history review could not be performed as no lot code was provided.Device and xrays were not reviewed for the related investigation.Conclusion: the root cause could not be determined because the devices were not returned for evaluation.

Event Description

It was reported that; on (b)(6) 2015, the patient underwent a 6-level spinal fusion (t10-l3) and a 3-level revision (l4-s1).The surgeon performed the surgery using products.Approximately 3 months after the surgery, the double-lock screw caps began to fail, causing the screws at l1-l2 to back out of place and the hardware to fall out of alignment.On (b)(6) 2016, the surgeon operated to replace the defective hardware and used triple-lock screw caps to secure the new hardware.My son continued to have constant pain and mobility problems.Further ct scans revealed the double-lock screw caps, from the december surgery, at l4-s1 had failed.This hardware failure caused the screws to back out of place and the hardware to fall out of alignment.In addition, some of these screws were holding a rod in place.Without the screws holding it in place, the rod was literally banging around the base of the spine.On (b)(6) 2016, the surgeon replaced all the defective hardware, replaced the rod which was now damaged, and used the triple-lock screw caps to hold everything in place.These two surgeries caused the patient extreme pain, all because of hardware failures.

• Brand Name: AVS UNILIF SPACER 10 X 30 X 0DEG - 11MM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6089750
• MDR Text Key: 59498947
• Report Number: 0009617544-2016-00445
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48351100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR