Skip to content

Instruments 6900430Recalls & reported problems

Nuvasive, Inc. · ALGI Rongeur, Pituitary Medium · Class 1

Adverse event reports
8
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00887517385819), received between Oct 14, 2022 and Apr 2, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 reports).

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture7
  • Material Separation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions8

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 2, 2025Fracture; Fracture

    DURING A PROCEDURE, THE DISTAL ARTICULATING TIP OF THE PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21753146 ↗
  • MalfunctionMar 31, 2025Fracture; Fracture

    DURING A PROCEDURE, THE DISTAL ARTICULATING TIP OF THE PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21733120 ↗
  • MalfunctionMay 2, 2024Fracture; Fracture

    ON (B)(6) 2024 A PATIENT UNDERWENT A SPINAL SURGERY ON UNKNOWN LEVELS OF THE SPINE. DURING THE PROCEDURE THE DEVICE TIP FRACTURED IN PATIENT BUT WAS ABLE TO BE RETRIEVED WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19234388 ↗
  • MalfunctionJan 12, 2024Fracture; Fracture

    IT WAS REPORTED THAT DURING USE IN A PROCEDURE, THE JAW OF THE PITUITARY RONGEUR FRACTURED OFF. THE FRACTURED PORTION WAS RETRIEVED FROM THE SURGICAL SITE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18507974 ↗
  • MalfunctionAug 3, 2023Fracture; Fracture

    IT WAS REPORTED THAT DURING USE IN A PROCEDURE, THE UPPER JAW OF THE PITUITARY RONGEUR FRACTURED OFF. THE FRACTURED PORTION WAS RETRIEVED FROM THE SURGICAL SITE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17455824 ↗
  • MalfunctionMay 12, 2023Fracture; Fracture

    DURING A PROCEDURE, THE DISTAL ARTICULATING TIP OF A PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16924510 ↗
  • MalfunctionApr 27, 2023Material Separation; Material Separation

    ON (B)(6) 2023 A PATIENT UNDERWENT A DISCECTOMY PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. DURING DISC REMOVAL THE UPPER INSTRUMENT JAW FRACTURED OFF AFTER BEING WEDGED IN-BETWEEN THE VERTEBRAL BODIES. THE FRACTURED PORTION WAS REMOVED FROM THE PATIENT WITH ANOTHER INSTRUMENT AND THE SURGERY WAS COMPLETED WITH NO FURTHER ISSUES. NO ADVERSE PATIENT CONSEQUENCES REPORTED AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16824603 ↗
  • MalfunctionOct 14, 2022Fracture; Material Separation; Fracture; Material Separation

    NEW OR UPDATED INFORMATION LISTED ON SECTION H10.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15611206 ↗

Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices

All ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices →

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