MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL LUMBAR CAGE 26 X 32MM, 11MM, 08 DEG.; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number 48922618

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 05/18/2016

Event Type  Injury  

Event Description

It was reported that the doctor noticed on post op x ray that the anchor was backing out.

Manufacturer Narrative

Method: device history review, complaint history review, risk assesment result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Based on the sales rep's description of "the surgeon didn't double check if the anchor was locked after its insertion.It seemed like that the anchor tamps were bottomed out during insertion, but it is possible that one was not fully bottomed out." conclusion: the most likely cause of the reported event was determined to be user related.

Event Description

It was reported that the doctor noticed on post op x ray that the anchor was backing out.

• Brand Name: AERO AL LUMBAR CAGE 26 X 32MM, 11MM, 08 DEG.
• 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: 5721522
• MDR Text Key: 47289466
• Report Number: 0009617544-2016-00233
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07613327067699
• UDI-Public: (01)07613327067699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133328
• 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: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48922618
• Device Lot Number: 145782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2014
• 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: 65 YR