MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR VARIABLE SELF DRILLING SCREW 4X12MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	48824012
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, the reflex hybrid system was implanted with no known issue.On (b)(6) 2019, it was discovered that incompatible screws were used with the plate, the surgeon was notified.During a post-operative x-ray, the surgeon noted that the screws and plate were backing out.The patient was experiencing some pain and underwent revision surgery on (b)(6) 2019 to replace the plate and screws.
Event or Problem Description
On (b)(6) 2019, the reflex hybrid system was implanted with no known issue.On (b)(6) 2019, it was discovered that incompatible screws were used with the plate, the surgeon was notified.During a post-operative x-ray, the surgeon noted that the screws and plate were backing out.The patient was experiencing some pain and underwent revision surgery on (b)(6) 2019 to replace the plate and screws.
Additional Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device was discarded.Manufacturing records for this product were not reviewed because no lot numbers were provided as the parts were discarded after the revision surgery.The stryker rep reported that the screws used with the reflex -hybrid plate were aviator screws.The probable root cause of the plate backing out is caused by using the incorrect screws to secure a plate.From the surgical technique: ¿aviator drill bits are 10mm longer than the reflex hybrid drill bits and are not interchangeable.Also check the part numbers: reflex hybrid part numbers start with 485, and aviator part numbers start with 487.¿ ¿the stryker spine aviator anterior cervical plating (acp) system consists of bone plates that are available in a variety of sizes in order to help accommodate individual patient physiology and pathology and to help facilitate anterior stabilization of the cervical spine.The aviator plates are intended to be used with the aviator bone screws.¿ device discarded by the hospital.

• Brand Name: AVIATOR VARIABLE SELF DRILLING SCREW 4X12MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8522914
• Report Number: 0009617544-2019-00054
• Device Sequence Number: 16611927
• Product Code: KWQ
• UDI-Device Identifier: 07613252152590
• UDI-Public: 07613252152590
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

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: 48824012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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