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

Catalog Number 48922618

Device Problems Bent (1059); Material Deformation (2976)

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

Event Date 11/21/2016

Event Type  malfunction  

Event Description

It was reported that; anchor bent upon insertion.

Manufacturer Narrative

Device history review, complaint history review, risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The most likely cause of the reported event was determined to be related to: (1) the patient has hard bone quality; (2) pilot cutter was not used prior to the anchor insertion, which was recommended per surgical technique.

Event Description

It was reported that; anchor bent upon insertion.

• Brand Name: AERO AL LUMBAR CAGE 26 X 32MM, 11MM, 08 DEG.
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6182995
• MDR Text Key: 63072181
• Report Number: 3004024955-2016-00107
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48922618
• Device Lot Number: 1071985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2016
• 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