KARMA 75035-175Recalls & reported problems
Spinal Elements, Inc. · PEEK Cerclage · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840606116138), received between Jul 29, 2021 and Dec 11, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Adverse Event Without Identified Device or Use Problem2
- Fracture1
Patient problems
- Vertebral Fracture2
- Back pain1
- Discomfort1
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A MEETING ON NOVEMBER 13, 2025, SURGEON DESCRIBED PATIENT OUTCOMES IN WHICH THE PATIENT(S) DISPLAYED A PARS FRACTURE ADJACENT TO THE DEVICE PER CT SCAN DURING ROUTINE FOLLOW UP. CT SCAN NOT PROVIDED. THERE WAS NO FAILURE OF THE DEVICE, AND THE DEVICE REMAINS INTACT BUT THE CO-MORBIDITY IS ALLEGEDLY PROCEDURALLY RELATED. DATE(S) OF SURGERY IS UNKNOWN. SPECIFIC EVENT DATES ARE UNKNOWN. LEVEL(S) TREATED ARE UNKNOWN. REVISION OR PLANNED REVISION IS UNKNOWN. PATIENT STATUS IS UNKNOWN. ADDITIONALLY, THE NUMBER OF OCCURRENCES WAS NOT DISCLOSED.
Patient problems: Vertebral Fracture
MAUDE report 23782355 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024 THE BONE FIXATION CERCLAGE DEVICE WAS IMPLANTED. LEVELS BEING TREATED WERE L2-L4. REPORTEDLY ON (B)(6) 2024 PATIENT COMPLAINED OF PAIN. UPON FURTHER EVALUATION PATIENT HAD A LAMINAR PARS FRACTURE ON RIGHT SIDE ADJACENT TO THE FIXATION DEVICE. IN THE REGION OF THE FIXATION DEVICE THE FACET BONE WAS INTACT. THERE IS NO PLAN TO REVISE. PATIENT IS FEELING BETTER AND WILL CONTINUE TO BE MONITORED.
Patient problems: Back pain; Discomfort; Vertebral Fracture
MAUDE report 20844990 ↗MalfunctionJul 29, 2021Fracture; Fracture
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.
Patient problems: Failure of Implant
MAUDE report 12250085 ↗
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
- VersaTie 8510260Nuvasive, Inc. · Bone fixation cerclage, sublaminar3 reports
- LIGAPASS B08110005Medicrea International · Bone Fixation Cerclage, Sublaminar3 reports
- JAZZ LOCKImplanet · 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.