MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 14MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48552314
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon could not advance or back out screw after initially being inserted.Surgeon used polyaxial driver then used screwdriver and could not adjust screw.Had to helicopter screw out twice.Update; there was over an hour surgical delay to helicopter out screws then re insert them.(2x).
Additional Manufacturer Narrative
Method: risk assessment; results: device inspection, device history review, and complaint history review could not be performed, as the device was not returned and a valid lot code could not be obtained.Conclusion: the root cause is undetermined.
Event or Problem Description
It was reported that; surgeon could not advance or back out screw after initially being inserted.Surgeon used polyaxial driver then used screwdriver and could not adjust screw.Had to helicopter screw out twice.Update; there was over an hour surgical delay to helicopter out screws then re insert them.(2x).

• Brand Name: OASYS 3.5 X 14MM 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: 5829179
• Report Number: 0009617544-2016-00309
• Device Sequence Number: 481982
• Product Code: KWP
• UDI-Device Identifier: 04546540371683
• UDI-Public: (01)04546540371683
• 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): 07/05/2016

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: 48552314
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2016
• Supplement Report FDA Received Date: 10/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1