nanOss 3D ABGS 90-300-251004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846468049560), received between Oct 27, 2022 and Oct 27, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  OUR DISTRIBUTION PARTNER SURGALIGN REPORTED "POD #2 PATIENT COMPLAINS OF LEFT FOOT WEAKNESS. ACTIVITY LEVEL ON (B)(6) 2022 WAS BEDREST UNTIL NOON. OCCUPATIONAL THERAPY NOTED LLE WEAKNESS NOTED AT 2 MIN SIT TO STAND EXERCISE. PHYSICAL THERAPY NOTES GAIT DECREASED CADENCE, FOOT DROP LEFT, DECREASED LEFT HEAL STRIKE, HIP HIKE, STEP-TO AND TRUNK FLEXION. (B)(6) 2022 TRANSFER TO IP REHAB UNIT FOR DAILY OT/PT CARE."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15685649 ↗
• InjuryOct 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  OUR DISTRIBUTION PARTNER SURGALIGN REPORTED THE FOLLOWING "DOS (B)(6) 2022 ABLE TO VOID & USE COMMODE. POD#3 (B)(6) 2022 FEELS URGE TO VOID BUT NOT ABLE TO VOID. BLADDER SCAN >1000ML RESIDUAL; PT STRAIGHT CATHETERIZED. 4 HRS LATER SAME FEELING OF NEED TO VOID BUT NOT ABLE TO VOID. #18FR FOLEY CATHETER INSERTED. D/C HOSPITAL WITH FOLEY IN PLACE. VOIDING TRIAL 1 WEEK LATER (B)(6) 2022 FAILED. REPEAT VOIDING TRIAL (B)(6) 2022. SUCCESS. FOLEY CATHETER DISCONTINUED"

  Patient problems: Urinary Retention

  MAUDE report 15685557 ↗
• InjuryOct 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  OUR DISTRIBUTION PARTNER SURGALIGN REPORTED "AFTER CAGE INSERTED INTO DISC SPACE NOTICED CSF LEAK. MUSCULAR GRAFE, SURGICEL AND TISSEEL PLACED. DID NOT OBSERVE ACTIVE LEAKING. DEEP HEMOVAC DRAIN PLACED."

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 15685553 ↗