MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 12; SPINAL INTERLAMINAL FIXATION ORTHOSIS.

Catalog Number	48558312
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a screw on the left at c5 had to be removed, after removing blocker and getting rod out of the way, the surgeon was unable to access the screw head due to it being cold fused.Rocked screw back and forth too much, then used an alternative instrument and pulled screw out.This was not ideal and surgeon requested i send screw in to be analyzed.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: the screw was examined and found to have a tulip head that was jammed into the screw shank.Manufacturing files were reviewed and no anomalies were found.Conclusion: the probable cause is patient factors due to the screw being implanted and a constant force applied to the tulip head jamming it into the shank.
Event or Problem Description
It was reported that a screw on the left at c5 had to be removed, after removing blocker and getting rod out of the way, the surgeon was unable to access the screw head due to it being cold fused.Rocked screw back and forth too much, then used an alternative instrument and pulled screw out.This was not ideal and surgeon requested i send screw in to be analyzed.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 3.5 X 12
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6196350
• Report Number: 0009617544-2016-00500
• Device Sequence Number: 509699
• Product Code: KWP
• UDI-Device Identifier: 04546540596314
• UDI-Public: (01)04546540596314
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K072568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2017

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: 48558312
• Device Lot Number: 161490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 02/21/2017
• 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