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

Catalog Number	48922601
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; one of the blades bent during insertion.
Additional 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 or Problem Description
It was reported that; one of the blades bent during insertion.

• Brand Name: AERO AL FIXATION ANCHOR, 26MM, WHITE CARTRIDGE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 6352554
• Report Number: 3004024955-2017-00012
• Device Sequence Number: 16153677
• Product Code: OVD
• UDI-Device Identifier: 07613327065619
• UDI-Public: (01)07613327065619
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48922601
• Device Lot Number: 145785
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 04/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1