MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY THREE LEVEL PLATE SIZE 39; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811339
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the locking wing on plate bent upon screw insertion due to wing overhanging the screw hole.
Additional Manufacturer Narrative
Method: risk assesment; result: the plate was confirmed by the stryker rep to have a deformed spring bar.The stryker rep confirmed that no drill guides were used to prepare the screw holes.Conclusion: the cause is not using the recommended drill guides as per the stg.
Event or Problem Description
It was reported that; the locking wing on plate bent upon screw insertion due to wing overhanging the screw hole.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 39
• 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: 5780352
• Report Number: 0009617544-2016-00275
• Device Sequence Number: 1367279
• Product Code: KWQ
• UDI-Device Identifier: 07613252152262
• UDI-Public: (01)07613252152262
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K1422317
• 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): 06/14/2016

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: 48811339
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2016
• Supplement Report FDA Received Date: 09/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1