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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

Other Prosthesis, Intervertebral Disc devices

All Prosthesis, Intervertebral Disc devices →

Sources and updates

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