MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48558528
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon performed a c2-t1 pcf.When he placed the t1 screw on the right side, he used a radius thoracic sharp probe, tapped with a 3.5mm tap, then began implanting a 4.5x28mm non-biased screw.As he was finishing the screw insertion, the tulip head of the screw detached from the bone screw, breaking the screw.As a result, the surgeon was forced to extend his incision to t2 to place screws and attach rods.This caused a 45 minutes of additional surgical time.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; manufacturing files were reviewed and no anomalies were found.The stryker rep reported that the patient had good bone quality, good bone purchase (proper prep of the screw holes) and that the polyaxial screw was properly attached to a polyaxial screwdriver (as per stg).The possible root causes for the tulip separation include: screw misaligned for angular insertion into bone, hard bone and screw connected too tight to screw driver.
Event or Problem Description
It was reported that the surgeon performed a c2-t1 pcf.When he placed the t1 screw on the right side, he used a radius thoracic sharp probe, tapped with a 3.5mm tap, then began implanting a 4.5x28mm non-biased screw.As he was finishing the screw insertion, the tulip head of the screw detached from the bone screw, breaking the screw.As a result, the surgeon was forced to extend his incision to t2 to place screws and attach rods.This caused a 45 minutes of additional surgical time.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5645532
• Report Number: 0009617544-2016-00180
• Device Sequence Number: 553909
• Product Code: KWP
• UDI-Device Identifier: 04546540596444
• UDI-Public: (01)04546540596444
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2016

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: No Information
• Device Catalogue Number: 48558528
• Device Lot Number: 161405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2016
• Supplement Report FDA Received Date: 07/20/2016
• 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