MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 26; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811226
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; plate springbar broke.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.The spring bar was visually confirmed to be fractured.Manufacturing files were reviewed and no anomalies were found.The probable root cause is not preparing the screw holes prior to implanting the screws.
Event or Problem Description
It was reported that; plate springbar broke.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 26
• 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: 6437693
• Report Number: 0009617544-2017-00113
• Device Sequence Number: 830141
• Product Code: KWQ
• UDI-Device Identifier: 07613252152170
• UDI-Public: (01)07613252152170
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• 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): 05/24/2017

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 Catalogue Number: 48811226
• Device Lot Number: 169474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR