JAZZ LOCK
Received Feb 16, 2026 · Event occurred Feb 12, 2024
Report 3007675554-2025-00002 · MDR key 24342934
Device
Product problems
- Migration or Expulsion of Device
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
58 YR · Unknown
- Unspecified Infection
Narrative
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.
Description of Event or Problem
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.