JAZZ LOCKRecalls & reported problems
Implanet · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03607503507004), received between Feb 16, 2026 and Feb 16, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth3
- Migration or Expulsion of Device3
Patient problems
- Unspecified Infection2
- Inadequate Pain Relief1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2026Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth
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.
Patient problems: Inadequate Pain Relief
MAUDE report 24342935 ↗MalfunctionFeb 16, 2026Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth
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.
Patient problems: Unspecified Infection
MAUDE report 24342934 ↗MalfunctionFeb 16, 2026Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth
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 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)(4), FDA INVESTIGATOR ON JULY 4, 2025.
Patient problems: Unspecified Infection
MAUDE report 24342933 ↗
Other Bone Fixation Cerclage, Sublaminar devices
- TRANSLACE™ Spinal Tethering System 8219500Medtronic Sofamor Danek, Inc. · Bone fixation cerclage, sublaminar11 reports
- VersaTie 86101245Nuvasive, Inc. · Bone fixation cerclage, sublaminar4 reports
- KARMA 75035-175Spinal Elements, Inc. · Bone Fixation Cerclage, Sublaminar3 reports
- VersaTie 8510260Nuvasive, Inc. · Bone fixation cerclage, sublaminar3 reports
- LIGAPASS B08110005Medicrea International · Bone Fixation Cerclage, Sublaminar3 reports
- NILE™ Alternative Fixation System 5416-F04730-SGVB Spine LLC · Bone fixation cerclage, sublaminar2 reports
- VersaTie 8450001Nuvasive, Inc. · Bone fixation cerclage, sublaminar2 reports
- TRANSLACE™ Spinal Tethering System 8205300Medtronic Sofamor Danek, Inc. · Bone fixation cerclage, sublaminar2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.