MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 28; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811228
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the customer reported that when bending the plate with plate benders, the plate fractured.The plate was bent in one direction, as the plate was bent back the opposite way it fractured just below the spring bar.
Additional Manufacturer Narrative
The plate is bent on a preparation table away from the patient cavity.Per additional communication, it was determined that this is not a reportable event.
Event or Problem Description
It was reported that; the customer reported that when bending the plate with plate benders, the plate fractured.The plate was bent in one direction, as the plate was bent back the opposite way it fractured just below the spring bar.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 28
• 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: 5524142
• Report Number: 0009617544-2016-00132
• Device Sequence Number: 963831
• Product Code: KWQ
• UDI-Device Identifier: 07613252152187
• UDI-Public: (01)07613252152187
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 03/21/2016

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: 48811228
• Device Lot Number: 14F371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2016
• Supplement Report FDA Received Date: 07/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1