MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY THREE LEVEL PLATE SIZE 57; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	48811357
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	05/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon was doing a 3-6 acdf with a 57mm plate.He initially put all 8 screws in 2/3 of the way, not using the drill guide.He tightened down the screws at the top level and bottom level, and when he went to tighten down the screws at the middle levels, he noticed one of the wings had snapped out of the plate.He backed out all the screws, damaging some of the other locking wings.A new 57mm plates was installed successfully.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: the returned plate was confirmed to have deformed locking mechanisms.Manufacturing files were reviewed and no anomalies were found.Conclusion: the root cause is not using the drill guides as recommended.
Event or Problem Description
It was reported that; surgeon was doing a 3-6 acdf with a 57mm plate.He initially put all 8 screws in 2/3 of the way, not using the drill guide.He tightened down the screws at the top level and bottom level, and when he went to tighten down the screws at the middle levels, he noticed one of the wings had snapped out of the plate.He backed out all the screws, damaging some of the other locking wings.A new 57mm plates was installed successfully.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 57
• 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: 6635340
• Report Number: 0009617544-2017-00236
• Device Sequence Number: 1048790
• Product Code: KWQ
• UDI-Device Identifier: 07613252152323
• UDI-Public: (01)07613252152323
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• 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): 09/11/2017

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: 48811357
• Device Catalogue Number: 48811357
• Device Lot Number: 172296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1