MAUDE Adverse Event Report: IMPLANET JAZZ LOCK; Bone fixation cerclage, sublaminar

Lot Number	NKSPNFOM-1
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual expertise of jazz lock returned was performed by implanet and showed that the peek inserts were insufficiently inserted into the base.This may explain the surgeon's findings during the reoperation.A meeting with the surgeon was organised in order to reinforce the surgical technique and he continues use the jazz lock almost weekly in 2025.
Event or Problem Description
2x jazz band and 2x jazz lock used in a posterior lumbar fusion, (b)(6) 2024.Bands passed around the uiv+1 (l1) spinous process and tensioned around the rod bilaterally.Reoperation on (b)(6) 2024.Surgeon noted that in one lock connector both portions of the band were out of the lock connector and in for the second lock connector one portion of the band remained in the connector.The reason for the re-operation was patient was still symptomatic, so the reoperation was for further decompression, and they found slipping of the band upon inspection.Due to the patient's pathology, the surgeon extended the fixation up one level with pedicle screws and rods.Surgical indication : lumbar decompression and fusion.Type of construct: plif + pedicle screws + jazz lock.This report is made at that date further to the observations written in a form fda 483 by (b)(6), fda investigator on july 4, 2025.

• Brand Name: JAZZ LOCK
• Common Device Name: Bone fixation cerclage, sublaminar
• Manufacturer (Section D): IMPLANET; technopole bordeauxmontesquieu; allee francois magendie; martillac, 33650 ; FR 33650
• Manufacturer (Section G): IMPLANET; technopole bordeauxmontesquieu; allee francois magendie; martillac, 33650 ; FR 33650
• Manufacturer Contact: regis le couedic ; technopole bordeaux montesquieu; allee francois magendie; martillac, 33650 ; FR 33650
• MDR Report Key: 24342935
• Report Number: 3007675554-2025-00003
• Device Sequence Number: 9912518
• Product Code: OWI
• UDI-Device Identifier: 03607503507004
• UDI-Public: 03607503507004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 11/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2026
• Device Lot Number: NKSPNFOM-1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Unknown