MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.5 X 30; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Catalog Number	48144530
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Injury (2348)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned to manufacturer.
Event or Problem Description
It was reported that the surgeon was removing screws and the patient lost motor and ssep monitoring.A screw appeared to be cold welded with the tulip stuck to the screw shank in an angled position.The surgeon was able to remove the tulip and screw from the patient.The case has been aborted.Upon follow up, it was reported that the patient had a neurological deficit on one leg post operatively.
Additional Manufacturer Narrative
Product inspection could not be performed as the reported screw was discarded by the hospital staff and not available for evaluation.No lot # was provided, so a manufacturing record review could not be performed.No x-ray images were provided that would help clarify if the screw went too deep or wrong trajectory while removing it.Due to lack of information provided, the exact root cause of the reported event cannot be determined.
Event or Problem Description
It was reported that the surgeon was removing screws and the patient lost motor and ssep monitoring.A screw appeared to be coldwelded with the tulip stuck to the screw shank in an angled position.The surgeon was able to remove the tulip and screw from the patient.The case has been aborted.Upon follow up, it was reported that the patient had a neurological deficit on one leg post operatively.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 4.5 X 30
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7754513
• Report Number: 0009617544-2018-00188
• Device Sequence Number: 19162285
• Product Code: OSH
• UDI-Device Identifier: 04546540450012
• UDI-Public: 04546540450012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48144530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR