MAUDE Adverse Event Report: SPINAL ELEMENTS, INC KARMA; CORTICAL DRILL

Catalog Number	75311-095
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated and the complaint was confirmed.The canted coil portion of the flexible drill bit has unraveled and is seized up inside the drill handle.This mechanical failure has rendered the device non-functional.Evidence suggests that the drill tip became embedded in the bone while advancing the drill.The surgeon may have tried to break it free from the bone to released the drill.The condition of the drill indicates that the power hand piece was run in reverse resulting in the canted coil unraveling.Though this is reasonably foreseen misuse, the device was used in a way not intended per the instructions for use.
Event or Problem Description
During facet bone preparation for a facet stabilization for spinal fusion, the canted coil of the drill unwound and made the drill unfunctional.Backup drill was not available and direct decompression of the nerve root was performed and the fixation at that level was abandoned.Though the surgery was completed, the device could not be used as a result of the malfunction.There was a partial decortication of the bone as a result of attempting this procedure.Patient is asymptomatic.

• Brand Name: KARMA
• Common Device Name: CORTICAL DRILL
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92080
• MDR Report Key: 25143334
• Report Number: 3004893332-2026-00004
• Device Sequence Number: 21211380
• Product Code: LXH
• UDI-Device Identifier: 00840606158237
• UDI-Public: (01)00840606158237(10)251119(11)251110
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K242527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: Health Professional
• Device Catalogue Number: 75311-095
• Device Lot Number: 251119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 71 YR
• Patient Sex: Male