Mobi-C MB3776Recalls & reported problems
LDR Spine Usa, Inc. · MOBI-C IMPLANT M « STANDARD » 17x17 H6 US · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03662663002028), received between Jun 26, 2019 and Jul 17, 2025 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Disconnection2
- Misassembled2
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Positioning Problem1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions2
- Numbness1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED IN A PATIENT DURING IMPLANTATION. ANOTHER IMPLANT WAS USED AND THERE WAS NO PATIENT HARM OR PROCEDURAL IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22535960 ↗InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT REPORTED THAT THEY ARE CONSIDERING HAVING A FUSION SURGERY BECAUSE A MOBI-C IS "FAILING" AFTER LESS THAN 5 YEARS. SYMPTOMS INCLUDE PAIN IN LEFT ARM, NECK, BACK AND CHEST, AND NUMBNESS IN THE FINGERS OF BOTH HANDS. FURTHER INFORMATION IS UNAVAILABLE AT THIS TIME.
Patient problems: Numbness; Pain
MAUDE report 19924206 ↗MalfunctionApr 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A MOBI-C IMPLANT CAME OFF THE CARTRIDGE HOLDER/INSERTER WHILE TRYING TO REPOSITION IT AFTER IT WAS IMPLANTED. THERE WAS NO REPORTED PATIENT HARM: ALL THREE IMPLANT PIECES WERE ACCOUNTED FOR AND REMOVED PRIOR TO IMPLANTATION OF THE FINAL DEVICE USED TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14073923 ↗MalfunctionJul 9, 2019Disconnection; Misassembled; Positioning Problem; Disconnection; Misassembled; Positioning Problem
THIS REPORT WAS CREATED IN ERROR. IT IS A DUPLICATE OF 3004788213-2019-00197.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8770987 ↗MalfunctionJul 9, 2019Misassembled; Insufficient Device Problem Information; Misassembled; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING THE PROCEDURE THE BOTTOM ENDPLATE OF THE IMPLANT LOOKED CROOKED. AN ALTERNATE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACT.S
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8770973 ↗MalfunctionJun 26, 2019Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER IMPLANTING THE DEVICE, THE SURGEON ATTEMPTED TO ADJUST THE POSITION OF THE IMPLANT. THE IMPLANT DISASSEMBLED, SHE REMOVED AND REPLACED IT WITH AN ALTERNATE TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8733850 ↗
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- Prodisc C SK PDSXL5Centinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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