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	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a posterior thoracic revision case while removing a screw, the tulip head snapped off leaving the thread implanted.Additionally, while removing implants, several instruments were damaged/stripped or broken.
Additional Manufacturer Narrative
Risk assessment.Manufacturing files were not reviewed because no parts or lot was provided.Device history review, device inspection and complaint history could not be performed because the device was not returned.The exact root cause of the tulip disengagement is not determined.
Event or Problem Description
It was reported that during a posterior thoracic revision case while removing a screw, the tulip head snapped off leaving the thread implanted.Additionally, while removing implants, several instruments were damaged/stripped or broken.

• 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: 5945561
• Report Number: 0009617544-2016-00361
• Device Sequence Number: 13477272
• Product Code: KWP
• UDI-Device Identifier: 04546540596451
• UDI-Public: (01)04546540596451
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K072568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2016

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 Catalogue Number: 48558532
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 11/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1