MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVS TL SPACER 12 X 30 X 4 DEG; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48370124
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	12/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an implant was warped on the area where the inserter is suppose to attach to the implant.Because of that the implant wouldn't stay attached to the inserter it keep falling off.
Additional Manufacturer Narrative
Risk assessment; device was discarded and lot# was not provided therefore device evaluation, device history review and complaint history review could not be performed.Without the device evaluation, the exact root cause cannot be determined conclusively.
Event or Problem Description
It was reported that an implant was warped on the area where the inserter is suppose to attach to the implant.Because of that the implant wouldn't stay attached to the inserter it keep falling off.

• Brand Name: AVS TL SPACER 12 X 30 X 4 DEG
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6234200
• Report Number: 0009617544-2017-00006
• Device Sequence Number: 858009
• Product Code: MQP
• UDI-Device Identifier: 07613153046462
• UDI-Public: (01)07613153046462
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042571
• 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): 03/17/2017

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: 48370124
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 03/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1