ProMIS™ Fixation System 86242Recalls & reported problems
Premia Spine Ltd · Pre-Bent Rod Ø6.0x50mm R128 Hex Edge · 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 07290014064980), received between Jun 29, 2022 and Jun 29, 2022 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE COMPANY WAS INFORMED ABOUT A SUPPLEMENTAL FIXATION SURGERY OF A PROMIS SYSTEM IN (B)(6) DUE TO DEGENERATIVE DISEASE IN ADJACENT LEVEL. THE SURGEON INDICATED THAT THE ORIGINAL SURGERY WAS AT LEAST 5 YEARS AGO AND INCLUDED L2/L3 FIXATION WITH THE PROMIS SYSTEM AND A CAGE, AND THAT THE REASON FOR THE SUBSEQUENT SURGERY WAS COMMON ADJACENT DDD AND NOT IMPLANT RELATED. IN THE SUPPLEMENTAL FIXATION SURGERY ADDITIONAL MICROSCOPIC DECOMPRESSION WAS PERFORMED, THE RODS WERE REPLACED WITH TWO 80MM PROMIS RODS AND TWO PEDICLE SCREWS WERE ADDED, WITH A CAGE BETWEEN L3/L4. NO FAILURE IN THE PROMIS RODS/SCREWS OR THEIR POSITIONING WAS INDICATED. THE SCREWS WERE INTACT AND WELL POSITIONED AND NOT REMOVED. THE RODS THAT WERE REPLACED WERE NOT RETURNED AND WERE THEREFORE NOT AVAILABLE FOR FURTHER INVESTIGATION. NO ADDITIONAL INFORMATION OTHER THAN IMPLANT IDENTIFICATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 14850100 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.