MAUDE Adverse Event Report: XENON LUMBAR SPINAL FIXATION SYSTEM; LXH

Model Number	22TRV12US
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned instrument revealed two of the three 2.30mm prongs/teeth were actually missing from the device.The polyaxial screw adjustment tool is intended to adjust the screw head/tulip to allow for proper alignment for rod insertion.Information provided indicated it was being utilized for screw removal.The xenon surgical technique guide (lit-84134) provides direction to properly perform revision and/or removal of previously implanted set screws, rods & pedicle screws.The original instrumentation set contains all instruments required to perform this process.
Event or Problem Description
During the case one of the prongs broke off the instrument which affected the ability to remove the fourth screw.The event cause over a 30 minute delay in the case.

• Brand Name: XENON LUMBAR SPINAL FIXATION SYSTEM
• Common Device Name: LXH
• MDR Report Key: 9570840
• Report Number: 2027467-2019-00064
• Device Sequence Number: 19353329
• Product Code: LXH
• UDI-Device Identifier: 00840967190228
• UDI-Public: (01)00840967190228(10)6375603
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 22TRV12US
• Device Catalogue Number: 22TRV12US
• Device Lot Number: 6375603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization