MOSS 175570000Recalls & reported problems
Depuy Spine, LLC · MOSS MIAMI SPINE SYSTEM ROD 5.5 x 480mm · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034034133), received between Mar 12, 2019 and May 9, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 2019Break; Break
POSTOPERATIVE ROD BREAKAGE . IT WAS REPORTED THAT PATIENT ACCEPTED SCOLIOSIS CORRECTION AND INTERNAL FIXATION ON (B)(6) 2016. NO ABNORMALITY WAS OBSERVED DURING PROCEDURE. 2 YEARS LATER, THE PATIENT WAS UNCOMFORTABLE AND RETURNED HOSPITAL. IT WAS FOUND ROD BROKE ON (B)(6), 2018. THE BROKEN ONE WAS REMOVED AND REVISION SURGERY WAS OPERATED ON (B)(6), 2019. THEN PATIENT CONDITION CHANGED BETTER. NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Code Available
MAUDE report 8595463 ↗InjuryMar 12, 2019Break; Break
BREAKAGE POST-OP. IT WAS REPORTED THAT THE PATIENT FELT PAINFUL FROM (B)(6) OF 2018, SEATED ON THE SOFA AND HEARD "GEDENG" SOUND ON (B)(6) 2018. AFTER A MOMENT, COULD WALK SLOWLY, BUT 2 DAYS LATER, FELT MUCH MORE PAIN, WENT TO HOSPITAL AND IT WAS FOUND THAT THE IMPLANT WAS BROKEN. 2ND SURGERY WAS DONE ON (B)(6) 2018, AND THE BROKEN ROD REMOVED. THE 1ST SURGERY WAS DONE ON (B)(6) 2013. NOW THE PATIENT IS STABLE AND LEFT FROM THE HOSPITAL. THE BROKEN ROD WAS RETAINED BY PATIENT.
Patient problems: No Code Available
MAUDE report 8413829 ↗
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- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.