MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR FIXED SELF DRILLING SCREW 4X14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48844014
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient had a primary surgery to the cervical spine (b)(6) 2014.In 2018 it was confirmed that he had neck kyphosing and screw loosening.Revision acdf/ corpectomy was performed on (b)(6) 2018.The surgeon removed a previously implanted 2 level aviator plate and screws from the patients cervical spine.Upon removal of one of the screws, the screw had fractured in half and only half the screw was removed from the patient.When removing additional screws, it was noticed the spring bar locking mechanism of the plate was damaged.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, labelling review, risk assessment.Result: the screw was confirmed visually to have fractured.Manufacturing files were reviewed and no anomalies were found.Conclusion: the screw was broken due to removal.The root cause could not be determined conclusively.Possible root causes include: poor bone screw pruchase, screw pathway not prepared properly, incorrect trajectory of screw, screw not seated below springbar before final blocker was turned, guide was not used to insert/prepare screw, incompatible tolerances, screw interferes with spring bar, blocker not unlocked prior to screw insertion, blocker head/screw stripped, incorrect geometry, incorrect screwdriver used to final tighten, stripped screw threads, blocker was unlocked/locked several times, screws were inserted and removed multiple times comprimising spring bar functionality.
Event or Problem Description
It was reported that a patient had a primary surgery to the cervical spine (b)(6) 2014.In 2018 it was confirmed that he had neck kyphosing and screw loosening.Revision acdf/ corpectomy was performed on (b)(6) 2018.The surgeon removed a previously implanted 2 level aviator plate and screws from the patients cervical spine.Upon removal of one of the screws, the screw had fractured in half and only half the screw was removed from the patient.When removing additional screws, it was noticed the spring bar locking mechanism of the plate was damaged.

• Brand Name: AVIATOR FIXED SELF DRILLING SCREW 4X14MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7584653
• Report Number: 0009617544-2018-00136
• Device Sequence Number: 13497254
• Product Code: KWQ
• UDI-Device Identifier: 07613252254706
• UDI-Public: (01)07613252254706
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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 Model Number: 48844014
• Device Catalogue Number: 48844014
• Device Lot Number: FL2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR