MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS SPACER 8 X 20 X 4 DEG - 9; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number 6760084

Device Problems Inadequacy of Device Shape and/or Size (1583); Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 03/30/2016

Event Type  Injury  

Event Description

It was reported that; on (b)(6) 2013, the patient underwent the surgery.On (b)(6) 2016, the surgeon confirmed x-ray.And he found that cage backed out.And the neurologic symptoms were seen by a patient.Therefore the surgeon did the revision surgery on (b)(6) 2016.Surgeon's comment: the size in chosen cage was small.There was little compression.

Manufacturer Narrative

Method: risk assesment.Result: the reported event of implant migration/pull out was confirmed via stryker sales rep.No device returned and no lot# was provided therefore, device inspection, device history review and complaint history review could not be performed.Conclusion: according to the surgeon's comment provided in the reported event, the size of the cage was small and there was little compression.This may likely have resulted too much load on patients spine.The probable root cause of this event in patient or user error - choosing the wrong size implant.

Event Description

It was reported that: on (b)(6) 2013, the patient underwent the surgery.On (b)(6) 2016, the surgeon confirmed x-ray.And he found that cage backed out.And the neurologic symptoms were seen by a patient.Therefore the surgeon did the revision surgery on (b)(6) 2016.Surgeon's comment: the size in chosen cage was small.There was little compression.

• Brand Name: AVS SPACER 8 X 20 X 4 DEG - 9
• 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: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5740194
• MDR Text Key: 47893657
• Report Number: 0009617544-2016-00242
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6760084
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2016
• 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