MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 4.0 X 26MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48552426
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; while inserting a screw, the screw head stripped and we were unable to insert or remove the screw.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.The definitive root cause of the event cannot be determined from the given information.
Event or Problem Description
It was reported that; while inserting a screw, the screw head stripped and we were unable to insert or remove the screw.

• Brand Name: OASYS 4.0 X 26MM POLYAXIAL SCREW
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6852868
• Report Number: 0009617544-2017-00353
• Device Sequence Number: 899190
• Product Code: KWP
• UDI-Device Identifier: 04546540371829
• UDI-Public: (01)04546540371829
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: 48552426
• Device Catalogue Number: 48552426
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1