TRANSLACE™ Spinal Tethering System 8219500 (UDI 00643169726925)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · TETHER 8219500 TETHER · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169726925), received between Apr 18, 2022 and Apr 18, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Expulsion” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Expulsion1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2022Expulsion; Expulsion
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING REVISION SURGERY. INITIAL SURGERY OF TH4-L1 POSTERIOR SPINE FIXATION WAS PERFORMED ON (B)(6)2018. IT WAS REPORTED THAT THERE WAS IMPLANT PROTRUSION ON THE DORSAL SIDE. THE IMPLANT IS REMOVED AND THE PATIENT HAD RECOVERED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14133403 ↗
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
- LIGAPASS B08110005Medicrea International · Bone Fixation Cerclage, Sublaminar3 reports
- KARMA 75035-175Spinal Elements, Inc. · Bone Fixation Cerclage, Sublaminar3 reports
- JAZZ LOCKImplanet · Bone Fixation Cerclage, Sublaminar3 reports
- VersaTie 8510260Nuvasive, Inc. · 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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