MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY FOUR LEVEL PLATE SIZE 72; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number	48811472
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	01/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the locking mechanism broke.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment the returned device was confirmed to have deformed spring bar upon visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.The probable root cause is using a power drill which is not mentioned in the surgical technique for screw hole preparation.
Event or Problem Description
It was reported that the locking mechanism broke.

• Brand Name: AVIATOR ASSY FOUR LEVEL PLATE SIZE 72
• 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: 5448829
• Report Number: 0009617544-2016-00069
• Device Sequence Number: 281082
• Product Code: KWQ
• UDI-Device Identifier: 07613252152415
• UDI-Public: (01)07613252152415
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 48811472
• Device Lot Number: 151423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2016
• Supplement Report FDA Received Date: 04/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR