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

Model Number	75035-175
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's ct imaging depicts a fracture in the sub laminar cerclage device below the locking buckle.The devices were 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 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) 2021 it was reported that the bone fixation cerclage device broke on the left l5-s1 near the locking buckle.No other event information was provided.No plan to revise.Patient is fine.

• 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: 12250085
• Report Number: 3004893332-2021-00008
• Device Sequence Number: 19943729
• Product Code: OWI
• UDI-Device Identifier: 00840606116138
• UDI-Public: 00840606116138
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K190289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75035-175
• Device Catalogue Number: 75035-175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1