nanOss ABGS 90-100-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846468049454), received between Feb 12, 2019 and Feb 12, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JANUARY 05, 2018, THE PATIENT REPORTED TO THE FDA THE FOLLOWING UNDER MW5081899: "PT CALLED TO REPORT ADVERSE EVENTS INVOLVING HER PS3 SPINAL SYSTEM (SHE HAD IMPLANTED ON (B)(6) 2014. PT STATED THAT AFTER THE INITIAL SURGERY SHE FELT GOOD. PT SAID ONE DAY SHE WOKE UP AND COULDN'T WALK OR STAND, AND HER PHYSICIAN SAID IT WAS BECAUSE SHE HAD LOOSENING OF THE DEVICE AND BROKEN HARDWARE. PT SAID SHE HAD A REVISION SURGERY ON (B)(6) 2016 TO FIX THE PROBLEMS, BUT NEVER FELT RELIEF AFTER THIS SURGERY. PT SAID SHE CONTINUALLY JUST KEPT GETTING WORSE, HAVING PAIN, AND COULDN'T MOVE OR STAND. PT SAID SHE KEPT INSISTING TO HER PHYSICIAN THAT SOMETHING WAS NOT RIGHT. PT SAID SHE HAD A SECOND REVISION SURGERY ON (B)(6) 2017 WHICH ONLY CAUSED HER EVEN MORE PROBLEMS. PT'S SYMPTOMS ARE: ITCHING, SWELLING AT INCISION SITE, RAW SPOTS, BURNING FEELING, INCONTINENCE, CAN'T SIT, WALK OR STAND FOR A LONG AMOUNT OF TIME, CONSTANT EXTREME PAIN, TINGLING AND NUMBNESS IN HANDS, LEGS AND FEET, LEGS LOOK PURPLE, BRUISING, HEADACHES, METAL TASTE IN MOUTH, RUINED SEX DRIVE, AND DEPRESSION. PT STATED SHE REQUESTED A DEVICE INFO CARD FROM PHYSICIAN, BUT THE PHYSICIAN REFUSED AND THEN TERMINATED HER AS A PT. PT

  Patient problems: Bruise/Contusion; Depression; Headache; Incontinence; Itching Sensation; Numbness; Swelling; Tingling

  MAUDE report 8332650 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT REPORTED TO THE FDA THE FOLLOWING UNDER MW5081899: "PT CALLED TO REPORT ADVERSE EVENTS INVOLVING HER PS3 SPINAL SYSTEM (SHE HAD IMPLANTED ON (B)(6) 2014. PT STATED THAT AFTER THE INITIAL SURGERY SHE FELT GOOD. PT SAID ONE DAY SHE WOKE UP AND COULDN'T WALK OR STAND, AND HER PHYSICIAN SAID IT WAS BECAUSE SHE HAD LOOSENING OF THE DEVICE AND BROKEN HARDWARE. PT SAID SHE HAD A REVISION SURGERY ON (B)(6) 2016 TO FIX THE PROBLEMS, BUT NEVER FELT RELIEF AFTER THIS SURGERY. PT SAID SHE CONTINUALLY JUST KEPT GETTING WORSE, HAVING PAIN, AND COULDN'T MOVE OR STAND. PT SAID SHE KEPT INSISTING TO HER PHYSICIAN THAT SOMETHING WAS NOT RIGHT. PT SAID SHE HAD A SECOND REVISION SURGERY ON (B)(6) 2017 WHICH ONLY CAUSED HER EVEN MORE PROBLEMS. PT'S SYMPTOMS ARE: ITCHING, SWELLING AT INCISION SITE, RAW SPOTS, BURNING FEELING, INCONTINENCE, CAN'T SIT, WALK OR STAND FOR A LONG AMOUNT OF TIME, CONSTANT EXTREME PAIN, TINGLING AND NUMBNESS IN HANDS, LEGS AND FEET, LEGS LOOK PURPLE, BRUISING, HEADACHES, METAL TASTE IN MOUTH, RUINED SEX DRIVE, AND DEPRESSION. PT STATED SHE REQUESTED A DEVICE INFO CARD FROM PHYSICIAN, BUT THE PHYSICIAN REFUSED AND THEN TERMINATED HER AS A PT. PT SAID

  Patient problems: Bruise/Contusion; Depression; Headache; Incontinence; Itching Sensation; Numbness; Swelling; Tingling

  MAUDE report 8331966 ↗