MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO AL LUMBAR CAGE 26 * 32MM, 13MM, 12 DEG.; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48922632

Device Problem Mechanical Jam (2983)

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

Event Date 12/10/2014

Event Type  malfunction  

Event Description

It was reported that the aero-al anchors became jammed against each other in inserter.

Manufacturer Narrative

Method: device inspection, material analysis and device history review.Results: device history indicated all devices accepted into final stock met specifications.Visual inspection indicated the returned anchors were confirmed to be jammed inside the returned inserter guide.Materials analysis results indicate that the deformation damage and cracking were observed in the anterior region of the 1st jammed anchor.The directionality of these damages would be consistent with the anchor hitting something while being inserted, stopping the anchor.These damages are likely related to the root cause of the 1st anchor jamming.Conclusion: the exact cause of these damages could not be determined.With anchor a jammed in the channel, anchor b could not be inserted past anchor a¿s location.Further loading to attempt anchor b¿s insertion exacerbated the jammed condition.

Event Description

It was reported that the aero-al anchors became jammed against each other in inserter.

• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4400131
• MDR Text Key: 19805113
• Report Number: 0009617544-2015-00016
• Device Sequence Number: 1
• Product Code: OVD
• 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: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48922632
• Device Lot Number: 145783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2014
• 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