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

Model Number 75035-175

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 06/30/2021

Event Type  malfunction  

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 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
• Type of Device: SUB- LAMINAR BONE FIXATION CERCLAGE
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 12250085
• MDR Text Key: 264263198
• Report Number: 3004893332-2021-00008
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 00840606116138
• UDI-Public: 00840606116138
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 75035-175
• Device Catalogue Number: 75035-175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1