MAUDE Adverse Event Report: SPINAL ELEMENTS, INC KARMA; SPINAL FACET DEVICE

Catalog Number	75035-175
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allegedly ct imaging depicted a crack/pars fracture of the lamina adjacent to the cerclage device.Device is intact.Ct images were not provided.There is no allegation of failure of the device.The device was not returned (remains in-situ) and therefore could not be evaluated.The intended use/surgical technique instructs placement of the device followed by a laminectomy (as needed) to ensure procedure and adjacent bone purchase are not compromised.Aggressive direct decompression (laminectomy) may compromise the bone structure.Surgeon indicates he performs laminectomy prior to the implantation of the device.The extent of decompression is unknown.Unknown factors include: patient's bone quality, patient activity at the time or prior to the event, the degree of spinal instability, stress and forces affecting the device or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported.) root cause or specific failure mode cannot be determined.
Event or Problem Description
During a meeting on november 13, 2025, surgeon described patient outcomes in which the patient(s) displayed a pars fracture adjacent to the device per ct scan during routine follow up.Ct scan not provided.There was no failure of the device, and the device remains intact but the co-morbidity is allegedly procedurally related.Date(s) of surgery is unknown.Specific event dates are unknown.Level(s) treated are unknown.Revision or planned revision is unknown.Patient status is unknown.Additionally, the number of occurrences was not disclosed.

• Brand Name: KARMA
• Common Device Name: SPINAL FACET DEVICE
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• MDR Report Key: 23782355
• Report Number: 3004893332-2025-00005
• Device Sequence Number: 15809711
• Product Code: MRW
• UDI-Device Identifier: 00840606116138
• UDI-Public: 00840606116138
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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 Catalogue Number: 75035-175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown