MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 34; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Model Number	48811234
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	08/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that locking mechanism was damaged during screw removal.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: visual inspection confirmed the spring bar was deformed.Manufacturing files were reviewed and no anomalies were found.Conclusion: the possible root causes include:screw not fully seated below spring bar, poor visibility of spring-bar, spring-bar damaged prior to use, blocker locked before visual confirmation of screw below spring bar.
Event or Problem Description
It was reported that locking mechanism was damaged during screw removal.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 34
• 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: 6870057
• Report Number: 0009617544-2017-00358
• Device Sequence Number: 19213225
• Product Code: KWQ
• UDI-Device Identifier: 07613252152217
• UDI-Public: (01)07613252152217
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083562
• 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): 01/10/2018

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: 48811234
• Device Catalogue Number: 48811234
• Device Lot Number: 171771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1