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

Lot Number	MQXZ-LXJM
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual expertise of jazz lock implants returned by dr.(b)(6) seems to indicate that this "loosening" of the braids is not the consequence of a locking anomaly of the jazz lock implants.The most likely hypothesis to explain the loosening of the assembly would be insufficient tension applied during the initial surgery on (b)(6) 2024.However, the elements in our possession do not allow to determine with certainty the origin of this event.
Event or Problem Description
Two jazz band implants (lot#: 210954 and lot#: 220386) and two jazz lock implants (lot#: lxja-lxji and lot#: mqxz-lxjm) were implanted in a 58-year-old patient on (b)(6) 2024 at (b)(6) hospital (usa) during a posterior lumbar fusion surgery.Revision surgery was performed on (b)(6) 2024 due to infection and the surgeon noted that the bands were "loose".This report is made at that date further to the observations written in a form fda 483 by mr (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: 24342934
• Report Number: 3007675554-2025-00002
• Device Sequence Number: 21310339
• 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: 02/28/2026
• Device Lot Number: MQXZ-LXJM
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2021
• 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