MAUDE Adverse Event Report: STRYKER SPINE-US AERO AL FIXATION ANCHOR, 26MM, WHITE CARTRIDGE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 48922601

Device Problems Bent (1059); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 01/27/2017

Event Type  malfunction  

Event Description

It was reported that; one of the blades bent during 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.Visual, dimensional and functional analysis could not be performed as the device was not returned.The most likely cause of the reported event was determined to be related tol pilot cutter was not used prior to the anchor insertion, which was recommended per surgical technique.

Event Description

It was reported that; one of the blades bent during insertion.

• Brand Name: AERO AL FIXATION ANCHOR, 26MM, WHITE CARTRIDGE
• 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6352554
• MDR Text Key: 68502453
• Report Number: 3004024955-2017-00012
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 07613327065619
• UDI-Public: (01)07613327065619
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48922601
• Device Lot Number: 145785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2014
• 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