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TRANSLACE™ Spinal Tethering System 8205300 (UDI 00643169726918)Recalls & reported problems

Medtronic Sofamor Danek, Inc. · CONNECTOR 8205300 CONNECTOR · Class 2 · Implant

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 00643169726918), 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. How this data works · Data updated Oct 13, 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 14133399 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.