MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW CANCELLOUS DIA 3.5 X 14; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48557314
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; oasys system was used on c3-t1 pcf.Surgeon placed all of his screws and decided to take one out.When he tried backing out the screw, the tulip head broke off.He was able to remove the screw shank a few minutes later.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment; visual inspection showed the tulip was confirmed separated from the screw shank.Manufacturing records for this product were reviewed and no anomalies were found.The probable root cause is mis alignment of the screwdriver to the screw axis.
Event or Problem Description
It was reported that; oasys system was used on c3-t1 pcf.Surgeon placed all of his screws and decided to take one out.When he tried backing out the screw, the tulip head broke off.He was able to remove the screw shank a few minutes later.

• Brand Name: OASYS POLYAXIAL SCREW CANCELLOUS DIA 3.5 X 14
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7005680
• Report Number: 0009617544-2017-00397
• Device Sequence Number: 1228584
• Product Code: KWP
• UDI-Device Identifier: 04546540596161
• UDI-Public: (01)04546540596161
• Combination Product (Y/N): N
• 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): 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48557314
• Device Catalogue Number: 48557314
• Device Lot Number: 157746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1