MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 22MM PA SCREW MEDIAL; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48555322
Medical Device Problem Codes	Disassembly (1168); Mechanical Problem (1384)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when removing a screw from the t1 vertebrae the tulip head of the screw fell off.The rest of the screw then came out without any harm to the patient.The screw will be sent back to you for further inspection.There was no harm done to the patient.Patient was fused at those levels they were taking the screws out.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assesment.Result: the returned device was inspected and it was confirmed that the tulip head was disengaged from the main screw body.Further inspection found deformation on the inner collar on the bottom of the tulip head and on the top of the screw body implying multiple excessive force applied during the removal of the implant.Upon manufacturing history review, no relevant manufacturing issues found.Deformations observed on the inner collar on the bottom of the tulip head and on the top of the screw body implies that multiple excessive force was applied during the removal of the implant.Conclusion: the possible root cause of this event is due to excessive torsional or cantilever force applied onto the implant during the removal process.
Event or Problem Description
It was reported that; when removing a screw from the t1 vertebrae the tulip head of the screw fell off.The rest of the screw then came out without any harm to the patient.The screw will be sent back to you for further inspection.There was no harm done to the patient.Patient was fused at those levels they were taking the screws out.

• Brand Name: OASYS 3.5 X 22MM PA SCREW MEDIAL
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5759563
• Report Number: 0009617544-2016-00264
• Device Sequence Number: 16147787
• Product Code: KWP
• UDI-Device Identifier: 04546540469540
• UDI-Public: (01)04546540469540
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142741
• 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): 06/07/2016

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: 48555322
• Device Lot Number: 13D294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2016
• Supplement Report FDA Received Date: 09/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1