Mobi-C MB3775Recalls & reported problems
LDR Spine Usa, Inc. · MOBI-C IMPLANT M « STANDARD » 17x17 H5 US · Class 3 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03662663002011), received between May 16, 2022 and Oct 17, 2024 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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
Most reported problems
Device problems
- Detachment of Device or Device Component5
- Fracture1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Neck Pain1
- Nerve Damage1
- Pain1
- Paraplegia1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED IN-SITU DURING IMPLANTATION. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20471395 ↗MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED DURING IMPLANTATION; DURING THE ADJUSTMENT PROCESS THE SUPERIOR ENDPLATE BECOME DISLODGED FROM THE PEEK HOUSING. THERE WAS NO IMPACT TO THE PATIENT; HOWEVER, THERE WAS A FIVE MINUTE DELAY WHILE A NEW IMPLANT WAS OPENED AND PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20031998 ↗MalfunctionJun 12, 2024Fracture; Fracture
IT WAS REPORTED THAT A MOBI-C IMPLANT BROKE WHILE TAMPING IN FOR FINAL POSITIONING AND IT DID NOT LOOK LIKE THE IMPLANT WAS MAINTAINING STABILITY. THE IMPLANT WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19521688 ↗MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT UPON USING THE FORCEPS TO PULL THE CARTRIDGE OFF OF THE MOBI-C IMPLANT IN THE DISC SPACE, THE CARTRIDGE GOT STUCK AND ROTATED THE BOTTOM ENDPLATE 90 DEGREES. ANOTHER IMPLANT WAS USED TO COMPLETE THE CASE. THERE WAS A 5-MINUTE DELAY WITHOUT IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18995532 ↗InjuryOct 14, 2022Malposition of Device; Malposition of Device
IT WAS REPORTED THAT A PATIENT HAD POST-OPERATIVE COMPLICATIONS AND PAIN IN THE RECOVERY ROOM AFTER A MOBI-C DEVICE WAS INSTALLED. DURING THE SURGERY, THE SURGEON FELT THE POSITION OF THE IMPLANT WAS UNACCEPTABLE, SO IT WAS REMOVED AND REPLACED WITH ANOTHER MOBI-C DEVICE OF THE SAME SIZE, CAUSING A 20 MINUTE DELAY TO THE PROCEDURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Neck Pain; Nerve Damage; Pain; Paraplegia
MAUDE report 15606177 ↗MalfunctionMay 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED INTRA-OPERATIVELY WHILE THE CARTRIDGE WAS BEING REMOVED; THE INFERIOR ENDPLATE PULLED OUT ABOUT 1MM. THE IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER ONE TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14517608 ↗MalfunctionMay 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE REMOVAL PLIERS WERE CATCHING THE PEEK CARTRIDGE AND PULLING OUT THE BOTTOM PORTION OF TWO MOBI-C IMPLANTS WHILE DETACHING THE CARTRIDGE AFTER INSTALLATION. BOTH MOBI-C IMPLANTS WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14408512 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.