MAUDE Adverse Event Report: STRYKER SPINE-FRANCE AVIATOR ASSY TWO LEVEL PLATE SIZE 34; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.

Catalog Number	48811234
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was trying to revise screw in a plate and spring lock locking device broke.
Additional Manufacturer Narrative
Catalog# 48811354.Method: risk assessment; results: manufacturing files were not reviewed because no parts or lot were provided.Conclusion: it appears that the surgical technique was followed for screw hole preparation (punch awl variable for use with self drilling screws) so the root cause is not determined due to lack of returned parts or lot number.
Event or Problem Description
It was reported that the surgeon was trying to revise screw in a plate and spring lock locking device broke.

• Brand Name: AVIATOR ASSY TWO LEVEL PLATE SIZE 34
• 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: 5606350
• Report Number: 0009617544-2016-00160
• Device Sequence Number: 20096
• Product Code: KWQ
• UDI-Device Identifier: 07613252152217
• UDI-Public: (01)07613252152217
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K083562
• 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): 03/28/2016

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: 48811234
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2016
• 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