MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 18MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48552318
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon struggled to back out screw after initially inserted.20min delay.Head of screw eventually broke off.Surgeon said inner head of screw stripped and screwdriver was no longer effective.
Additional Manufacturer Narrative
Risk assessment.Manufacturing records for this product were not reviewed because no lot or parts were provided.Potential root causes may be: screw misaligned for angular insertion into bone, hard bone and screw connected too tight to screw driver.
Event or Problem Description
It was reported that; surgeon struggled to back out screw after initially inserted.20min delay.Head of screw eventually broke off.Surgeon said inner head of screw stripped and screwdriver was no longer effective.

• Brand Name: OASYS 3.5 X 18MM 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: 6358180
• Report Number: 0009617544-2017-00063
• Device Sequence Number: 10907093
• Product Code: KWP
• UDI-Device Identifier: 04546540371706
• UDI-Public: (01)04546540371706
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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 Catalogue Number: 48552318
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1