MAUDE Adverse Event Report: SPINAL ELEMENTS, INC KARMA; SUB- LAMINAR BONE FIXATION CERCLAGE

Catalog Number	75035-175
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Vertebral Fracture (4520); Back pain (4895)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's ct imaging depicts a crack/pars fracture of the lamina adjacent to the cerclage device.Device is intact.The device was not returned to spinal elements as it remain in-situ and therefore could not be evaluated.There is no plan for revision.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 effecting 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
On (b)(6) 2024 the bone fixation cerclage device was implanted.Levels being treated were l2-l4.Reportedly on (b)(6) 2024 patient complained of pain.Upon further evaluation patient had a laminar pars fracture on right side adjacent to the fixation device.In the region of the fixation device the facet bone was intact.There is no plan to revise.Patient is feeling better and will continue to be monitored.

• Brand Name: KARMA
• Common Device Name: SUB- LAMINAR BONE FIXATION CERCLAGE
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• MDR Report Key: 20844990
• Report Number: 3004893332-2024-00008
• Device Sequence Number: 15478781
• Product Code: OWI
• UDI-Device Identifier: 00840606116138
• UDI-Public: 00840606116138
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K190289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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: 11/12/2024
• Initial Report FDA Received Date: 12/04/2024
• 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 Age: 73 YR
• Patient Sex: Male