Integra® NL8501212Recalls & reported problems
Integra Lifesciences Corporation · Side-Inlet Integra® CSF Reservoir Flat Bottom · 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 10381780024217), received between Nov 9, 2023 and Nov 9, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Material Perforation” (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
- Material Perforation1
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.
InjuryNov 9, 2023Material Perforation; Material Perforation
A FACILITY REPORTED THAT THE BOTTOM OF THE INTEGRA RESERVOIR 2.5CM DOME,FLAT BOTTOM, SIDE I (NL8501212) WAS PUNCTURED WITH A PORT NEEDLE (<22G) DURING PUNCTURE. THEREFORE, THE RESERVOIR HAD TO BE EXPLANTED. THERE WAS INCREASED SURGERY TIME OF AN HOUR (TIME FROM INDICATING THE PERFORATION IN THE OR UNTIL EXPLANTATION AND IMPLANTATION OF A NEW DEVICE). THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18108109 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.