MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY THREE LEVEL PLATE SIZE 45; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48811345
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the surgeon was trying to final lock the plate, one of the locking mechanisms wouldn't properly lock.It was free spinning.
Additional Manufacturer Narrative
Lot# unknown.Method: risk assessment; results: manufacturing files were not reviewed because no lot or parts were provided.The hospital disposed of the plate.Conclusion: it appears that the stg was followed, however a probable root cause is not determined due to no parts being returned.
Event or Problem Description
It was reported that when the surgeon was trying to final lock the plate, one of the locking mechanisms wouldn't properly lock.It was free spinning.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 45
• 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: 5574747
• Report Number: 0009617544-2016-00150
• Device Sequence Number: 16212981
• Product Code: KWQ
• UDI-Device Identifier: 07613252152286
• UDI-Public: (01)07613252152286
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/17/2016

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: 48811345
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2016
• Supplement Report FDA Received Date: 06/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1