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

Catalog Number	48558528
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw tulip head broke apart from the screw threads while in the patient.
Additional Manufacturer Narrative
Lot# 166294.Method: visual inspection, device history review, complaint history review, risk assessment; result: the device confirmed visually to have a separated tulip head.Manufacturing files were reviewed and no anomalies were found.Conclusion: the likely root causes for the tulip separation is not tapping the hole.
Event or Problem Description
It was reported that a screw tulip head broke apart from the screw threads while in the patient.

• 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: 6112867
• Report Number: 0009617544-2016-00464
• Device Sequence Number: 16424943
• Product Code: KWP
• UDI-Device Identifier: 04546540596444
• UDI-Public: (01)04546540596444
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072568
• 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): 01/24/2017

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: 48558528
• Device Lot Number: 166294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2016
• Supplement Report FDA Received Date: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1