MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL LUMBAR CAGE 30 X 38MM, 13MM, 12 DEG.; INTERVERTEBRAL BODY FUSION DEVICE.

Catalog Number 48923032

Device Problems Bent (1059); Component Missing (2306); Material Deformation (2976); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2016

Event Type  malfunction  

Event Description

It was reported that metal jacket was not around cage out of package; used back up cage.After implanting the back up cage.The cage blade bent upon insertion.Cutter was used.

Manufacturer Narrative

Device history review.Device not returned.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Due to the insufficient information and the device is still implanted in the patient, the root cause could not be determined conclusively.

Event Description

It was reported that metal jacket was not around cage out of package; used back up cage.After implanting the back up cage.The cage blade bent upon insertion.Cutter was used.

• Brand Name: AERO AL LUMBAR CAGE 30 X 38MM, 13MM, 12 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5469747
• MDR Text Key: 39678308
• Report Number: 0009617544-2016-00086
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07613327065602
• UDI-Public: 07613327065602
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48923032
• Device Lot Number: 145802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2014
• 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 Age: 38 YR