MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 32; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48558532
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/19/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; the tulip head broke off of screw at t1.The other screw also at t1 was stripped and unable to be removed or advanced further.Update (26-apr-2016): the stripped screw remains in patient.The detached tulip forced him to add extra level which added 45 min to case.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: manufacturing files were reviewed and no anomalies were found.The stryker rep reported that the patient had hard bone quality, that proper prep of the screw holes was completed and that the polyaxial screw was properly attached to a polyaxial screwdriver (as per stg).Conclusion: 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, however the exact root cause of the tulip disengagement is not determined.
Event or Problem Description
It was reported that; the tulip head broke off of screw at t1.The other screw also at t1 was stripped and unable to be removed or advanced further.Update (26-apr-2016): the stripped screw remains in patient.The detached tulip forced him to add extra level which added 45 min to case.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 32
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5661383
• Report Number: 0009617544-2016-00190
• Device Sequence Number: 18897562
• Product Code: KWP
• UDI-Device Identifier: 04546540596451
• UDI-Public: (01)04546540596451
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• 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): 04/20/2016

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: 48558532
• Device Lot Number: 160126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 07/22/2016
• 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: Other