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 Codes	Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	02/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the surgeon performed a c4-6 acdf and implanted a plate.After shooting an xray it was determined that a 16mm screw in c4 was too long and needed to be replaced with a 14mm screw.The surgeon utilized the rescue driver to back the screw out.The surgeon informed the operating room team that the locking spring bar broke off as the screw backed out.Consequently, the entire plate/screw construct had to be removed and replaced.When removing the screws from c5 the locking spring bar bent at that level as well.The rep confirmed that the screw driver had been fully engaged in the screw and that the locking hub had been in the unlocked position prior to backing the screw out.The surgeon confirmed that he had performed the removal per the technique.The plate was washed and autoclaved to be sent off for evaluation.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: manufacturing files were reviewed and no anomalies were found.The plate was confirmed visually to have fractured conclusion: possible causes of the spring bar popping out include cantilever the guide during removal from plate and bending the plate over the locking mechanisms as per the (b)(4).
Event or Problem Description
It was reported that; the surgeon performed a c4-6 acdf and implanted a plate.After shooting an xray it was determined that a 16mm screw in c4 was too long and needed to be replaced with a 14mm screw.The surgeon utilized the rescue driver to back the screw out.The surgeon informed the or team that the locking spring bar broke off as the screw backed out.Consequently, the entire plate/screw construct had to be removed and replaced.When removing the screws from c5 the locking spring bar bent at that level as well.The rep confirmed that the screw driver had been fully engaged in the screw and that the locking hub had been in the unlocked position prior to backing the screw out.The surgeon confirmed that he had performed the removal per the technique.The plate was washed and autoclaved to be sent off for evaluation.

• 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: 6384408
• Report Number: 0009617544-2017-00076
• Device Sequence Number: 650188
• Product Code: KWQ
• UDI-Device Identifier: 07613252152217
• UDI-Public: (01)07613252152217
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2017

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: 48811234
• Device Lot Number: 168843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR