Helix Locking Tool 5616Recalls & reported problems
Centerpoint Systems LLC · Class 1
- 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 00810024670291), received between Jul 13, 2026 and Jul 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Connection Problem” (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
- Connection Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2026Connection Problem
IT WAS REPORTED THAT THIS ACCESSORY HELIX LOCKING TOOL EXHIBITED LOOSENESS WITH THE INVOLVED LEAD DURING AN IMPLANT PROCEDURE RESULTING TO LEAD DISLODGEMENT. THE PATIENT HAD INFECTION WHICH WAS ATTRIBUTABLE TO THE UNDERLYING PATIENT CONDITION. THIS ACCESSORY WAS OUT OF SERVICE AND REPLACED WITH A NEW LOCKING TOOL RESULTING TO A COMPLETED PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 25800948 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.