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	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	11/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; cage became dis-attached from the inserter during implantation.While trying to further impact the cage and then attempting to remove it applied pressure on the spinal cord causing a decrease on the patients sensory during ssep monitoring.We eventually removed that cage and inserted a second one successfully.The second cage was eventually inserted correctly and the same inserter was used to complete the surgery.
Additional Manufacturer Narrative
Method: risk assessment.Results: device was not returned and lot# was not provided.Therefore device inspection, device history review and complaint history review could not be performed.Conclusion: without the device evaluation, the exact root cause cannot be determined conclusively.
Event or Problem Description
It was reported that; cage became dis-attached from the inserter during implantation.While trying to further impact the cage and then attempting to remove it applied pressure on the spinal cord causing a decrease on the patients sensory during ssep monitoring.We eventually removed that cage and inserted a second one successfully.The second cage was eventually inserted correctly and the same inserter was used to complete the surgery.

• 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: 6130519
• Report Number: 0009617544-2016-00475
• Device Sequence Number: 350131
• Product Code: MQP
• UDI-Device Identifier: 07613153046462
• UDI-Public: (01)07613153046462
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K042571
• 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): 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2016
• 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
• Outcome Attributed to Adverse Event: Other