MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 24; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48558524
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
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; the surgeon inserted a screw and decided to take it out because he didn't like the placement of the screw.When he tried to use the driver to remove the screw, the driver would not engage the inner nipple of the screw head because the inner nipple was stripped.He then inserted a rod and blocker and tried to "helicopter" the screw out, but the screw head broke off.He had to get a set of vice grips and use them to turn the screw to remove.After the case, the rep checked the drivers, and they are not stripped.The surgery was delayed about an hour.No other adverse consequences.
Additional Manufacturer Narrative
Manufacturing records for this product were not reviewed because no parts or lot were provided.Device inspection was not performed because the device was returned.The root cause is not determined.
Event or Problem Description
It was reported that; the surgeon inserted a screw and decided to take it out because he didn't like the placement of the screw.When he tried to use the driver to remove the screw, the driver would not engage the inner nipple of the screw head because the inner nipple was stripped.He then inserted a rod and blocker and tried to "helicopter" the screw out, but the screw head broke off.He had to get a set of vice grips and use them to turn the screw to remove.After the case, the rep checked the drivers, and they are not stripped.The surgery was delayed about an hour.No other adverse consequences.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 24
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6858880
• Report Number: 0009617544-2017-00354
• Device Sequence Number: 495635
• Product Code: KWP
• UDI-Device Identifier: 04546540596437
• UDI-Public: (01)04546540596437
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/18/2017

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: 48558524
• Device Catalogue Number: 48558524
• 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: 09/12/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR