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

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problems Neurological Deficit/Dysfunction (1982); Injury (2348)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

Device was not returned to manufacturer.

Event 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.

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 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
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7754513
• MDR Text Key: 116206554
• Report Number: 0009617544-2018-00188
• Device Sequence Number: 1
• Product Code: OSH
• UDI-Device Identifier: 04546540450012
• UDI-Public: 04546540450012
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 48144530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR