MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR FIXED SELF DRILLING SCREW 4X16MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	48844016
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician reported that the self-tapping screw appeared to have backed out via post op images.During exploratory revision surgery, it was noted that the locking wing of the plate on the same level as the backed-out screw, fractured.The backed-out screw was also noted to have fractured.The physician confirmed all the broken pieces were retrieved.The patients wound was inspected with blue die by an ent surgeon who confirmed there were no holes in the esophagus.Retrieval of the broken pieces was completed successfully with no adverse consequences.The locking wing would have been forced from its position and either deformed or fractured as the screw backed-out.This record represents the backed-out screw.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Product, complaint , and manufacturing history reviews could not be performed as a valid lot number was not provided and could not be obtained since the device was not returned.It was confirmed via x-ray that one aviator fixed self drilling screw migrated leading to a revision surgery for removal.Potential root caused based on the risk file: improper plate sizing or contouring; excessive post-op activity by patient (not recommended by surgeon); patient does not follow surgeon instructions; patient over exerts.If the explanted screw and locking bar fragment become available for examination, this investigation will be reopened and updated.
Event or Problem Description
Physician reported that the self-tapping screw appeared to have backed out via post op images.During exploratory revision surgery, it was noted that the locking wing of the plate on the same level as the backed-out screw, fractured.The backed-out screw was also noted to have fractured.The physician confirmed all the broken pieces were retrieved.The patients wound was inspected with blue die by an ent surgeon who confirmed there were no holes in the esophagus.Retrieval of the broken pieces was completed successfully with no adverse consequences.The locking wing would have been forced from its position and either deformed or fractured as the screw backed-out.This record represents the backed-out screw.

• Brand Name: AVIATOR FIXED SELF DRILLING SCREW 4X16MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8732909
• Report Number: 0009617544-2019-00082
• Device Sequence Number: 11406256
• Product Code: KWQ
• UDI-Device Identifier: 07613252254713
• UDI-Public: 07613252254713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 48844016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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
• Patient Age: 74 YR