MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AERO C CAGE 5MM INTERBODY DEVICE, 12DX14W PARALLEL; INTERVERTEBRAL BODY FUSION DEVICE.

Model Number	48892050
Medical Device Problem Codes	Detachment Of Device Component (1104); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; anchor would not fully insert into cage.Both the guided and freehand tamps were impacted forcefully against the partially inserted anchor, but the anchor would not progress further.The end of the anchor remains proud by approximately 1-2mm.There was a surgical delay of 5 minutes associated with several attempts to impact the anchor using both types of tamps in the set.The surgeon ultimately decided to leave the cage with the anchor remaining proud.Fluoroscopic image of implanted cage available.
Additional Manufacturer Narrative
No relevant manufacturing issues were identified as all units met specifications.Visual, dimensional and functional analysis could not be performed as the device was still implanted.The root cause could not be determined conclusively.
Event or Problem Description
It was reported that; anchor would not fully insert into cage.Both the guided and freehand tamps were impacted forcefully against the partially inserted anchor, but the anchor would not progress further.The end of the anchor remains proud by approximately 1-2mm.There was a surgical delay of 5 minutes associated with several attempts to impact the anchor using both types of tamps in the set.The surgeon ultimately decided to leave the cage with the anchor remaining proud.Fluoroscopic image of implanted cage available.

• Brand Name: AERO C CAGE 5MM INTERBODY DEVICE, 12DX14W PARALLEL
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6772610
• Report Number: 0009617544-2017-00302
• Device Sequence Number: 197611
• Product Code: MAX
• UDI-Device Identifier: 07613327124675
• UDI-Public: (01)07613327124675
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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 Model Number: 48892050
• Device Catalogue Number: 48892050
• Device Lot Number: 155721
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR