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

Model Number	48558528
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that when inserting a screw into t2 the poly head popped off the bone screw.
Additional Manufacturer Narrative
Stryker rep reported that the holes prepared with a stryker thoracic gear shift.The likely root cause of the tulip disengagement is improper preparation of the screw holes as recommended by the surgical technique.
Event or Problem Description
It is reported that when inserting a screw into t2 the poly head popped off the bone screw.

• 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: 6786687
• Report Number: 0009617544-2017-00313
• Device Sequence Number: 19111422
• Product Code: KWP
• UDI-Device Identifier: 04546540596444
• UDI-Public: (01)04546540596444
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K032394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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: 48558528
• Device Catalogue Number: 48558528
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR