ROI-CRecalls & reported problems across all models
LDR Spine Usa, Inc. · 39 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 167
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 0
We found 39 models of ROI-C by LDR Spine Usa, Inc. in the FDA's device registry (GUDID). Together they are named in 167 adverse event reports in the FDA's MAUDE database, received between May 2, 2019 and Aug 27, 2026 — classified as 19 injuries, 148 malfunctions.
The most frequently reported specific device problem is “Fracture” (92 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ROI-C problems
Device problems
- Fracture92
- Difficult to Insert20
- Break11
- Material Twisted/Bent10
- Physical Resistance/Sticking6
- Adverse Event Without Identified Device or Use Problem5
- Failure to Osseointegrate5
- Mechanical Jam5
Patient problems
- No Clinical Signs, Symptoms or Conditions103
- No Consequences Or Impact To Patient31
- No Known Impact Or Consequence To Patient14
- Numbness5
- Pain5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Discomfort3
- Hemorrhage/Blood Loss/Bleeding3
ROI-C models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ROI-C MC1005TIntervertebral Fusion Device With Bone Graft, Cervical54 reports
- ROI-C MC9091RIntervertebral Fusion Device With Integrated Fixation, Cervical13 reports
- ROI-C MC1006TIntervertebral Fusion Device With Bone Graft, Cervical11 reports
- ROI-C MC9001RIntervertebral Fusion Device With Integrated Fixation, Cervical11 reports
- ROI-C MC1342PIntervertebral Fusion Device With Bone Graft, Cervical10 reports
- ROI-C MC1312PIntervertebral Fusion Device With Bone Graft, Cervical5 reports
- ROI-C MC1434PIntervertebral Fusion Device With Integrated Fixation, Cervical5 reports
- ROI-C MC1442PIntervertebral Fusion Device With Integrated Fixation, Cervical5 reports
- ROI-C MC1321PIntervertebral Fusion Device With Bone Graft, Cervical4 reports
- ROI-C MC1313PIntervertebral Fusion Device With Bone Graft, Cervical3 reports
- ROI-C MC1320PIntervertebral Fusion Device With Bone Graft, Cervical3 reports
- ROI-C MC1332PIntervertebral Fusion Device With Bone Graft, Cervical3 reports
- ROI-C MC1343PIntervertebral Fusion Device With Bone Graft, Cervical3 reports
- ROI-C MC1443PIntervertebral Fusion Device With Integrated Fixation, Cervical3 reports
- ROI-C CMC1434PIntervertebral Fusion Device With Integrated Fixation, Cervical3 reports
- ROI-C MC1311PIntervertebral Fusion Device With Bone Graft, Cervical2 reports
- ROI-C MC1331PIntervertebral Fusion Device With Bone Graft, Cervical2 reports
- ROI-C MC1423PIntervertebral Fusion Device With Integrated Fixation, Cervical2 reports
- ROI-C MC1433PIntervertebral Fusion Device With Integrated Fixation, Cervical2 reports
- ROI-C CMC1322PIntervertebral Fusion Device With Integrated Fixation, Cervical2 reports
- ROI-C CMC1422PIntervertebral Fusion Device With Integrated Fixation, Cervical2 reports
- ROI-C CMC1443PIntervertebral Fusion Device With Integrated Fixation, Cervical2 reports
- ROI-C MC1314PIntervertebral Fusion Device With Bone Graft, Cervical1 report
- ROI-C MC1341PIntervertebral Fusion Device With Bone Graft, Cervical1 report
- ROI-C MC1351PSpinal Vertebral Body Replacement Device1 report
- ROI-C MC1352PIntervertebral Fusion Device With Bone Graft, Cervical1 report
- ROI-C MC1432PIntervertebral Fusion Device With Bone Graft, Cervical1 report
- ROI-C MC1445PIntervertebral Fusion Device With Integrated Fixation, Cervical1 report
- ROI-C MC1453PIntervertebral Fusion Device With Integrated Fixation, Cervical1 report
- ROI-C MC1454PIntervertebral Fusion Device With Integrated Fixation, Cervical1 report
- ROI-C CMC1311PIntervertebral Fusion Device With Integrated Fixation, Cervical1 report
- ROI-C CMC1332PIntervertebral Fusion Device With Integrated Fixation, Cervical1 report
- ROI-C CMC1431PIntervertebral Fusion Device With Integrated Fixation, Cervical1 report
- ROI-C CMC1432PIntervertebral Fusion Device With Integrated Fixation, Cervical1 report
- ROI-C CMC1442PIntervertebral Fusion Device With Integrated Fixation, Cervical1 report
- ROI-C CMC1451PIntervertebral Fusion Device With Integrated Fixation, Cervical1 report
- ROI-C MC9013RIntervertebral Fusion Device With Integrated Fixation, Cervical1 report
- ROI-C MC9027RIntervertebral Fusion Device With Integrated Fixation, Cervical1 report
- ROI-C SI-ROIC-0039Intervertebral Fusion Device With Integrated Fixation, Cervical1 report
Recent ROI-C adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Failure to Advance; Material Twisted/Bent
It was reported that when inserting the second anchoring plate of the ROI-C at C4/C5, it could not be advanced at all. When the plate was removed, it was found to be bent. It is suspected that the first plate had not been fully inserted, which may have caused interference with the second plate. The first plate was driven in again until it was fully seated. Another box was opened, and a replacement plate was used to continue the procedure. There were no reported patient impacts.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50484099 ↗MalfunctionAug 19, 2026Fracture
It was reported that during a two-level ROI-C procedure, the hook of the cage holder fractured. After the blade was inserted into the second level, the hook fractured while the surgeon was withdrawing the holder from the cage. The broken hook tip was ultimately found outside of the surgical site and there was no patient or procedural impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332891 ↗MalfunctionJul 10, 2026Fracture
Patient problems: Foreign Body In Patient
MAUDE report 25782426 ↗MalfunctionJul 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25769526 ↗MalfunctionJun 4, 2026Fracture
IT WAS REPORTED THAT A 14X17X6H ROI-C SPACER FRACTURED INTRA-OP. THE SPACER AND FRAGMENT WERE REMOVED AND REPLACED WITH ANOTHER SPACER. THERE WAS A 5 MINUTE DELAY WITHOUT PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399663 ↗MalfunctionApr 22, 2026Fracture
IT WAS REPORTED THAT AN ROI-C IMPLANT FRACTURED DURING INSERTION OF THE PLATE DURING AN EXTENSION SURGERY, BUT THAT THERE WAS NO PATIENT OR PROCEDURAL IMPACT AND A DIFFERENT SIZED IMPLANT WAS AVAILABLE FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955940 ↗MalfunctionFeb 11, 2026Malposition of Device
IT WAS REPORTED THAT TWO ROI-C CAGES FRACTURED INTRA-OPERATIVELY AT C6/7 WHILE IMPLANTING THE SUPERIOR PLATES BEFORE LOCKING. THE PLATES WERE MISALIGNED DESPITE USING THE AWL SUCCESSFULLY. THE LEVEL ABOVE HAD A PREVIOUS PLATE/SCREW CONSTRUCT AND THE PROCEDURE WAS AN EXTENSION OF THE PREVIOUSLY SUCCESSFUL FUSION. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITIVE PRODUCT. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 60 MINUTE DELAY. UPON INVESTIGATION IT WAS DISCOVERED THAT ONE OF THE PLATES WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24315176 ↗MalfunctionJan 26, 2026Difficult to Insert
IT WAS REPORTED THAT AN ROI-C ANCHORING PLATE WAS UNABLE TO BE INSERTED INTO THE PATIENT'S VERTEBRAL BODY BECAUSE THE BONE WAS TOO HARD. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24183940 ↗MalfunctionJan 13, 2026Difficult to Insert
IT WAS REPORTED THAT INTRA-OPERATIVELY, IT WAS IMPOSSIBLE TO IMPACT THE ROI-C ANCHORING PLATES DUE TO PATIENT HAVING TOO STRONG BONE. OTHER ANCHORS WERE USED TO COMPLETE THE SURGERY AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24059920 ↗MalfunctionDec 22, 2025Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THAT AT THE END OF A SURGERY, AFTER IMPACTING THE ROI-C ANCHORS, THE SURGEON NOTICED THAT A SMALL PIECE OF METAL WAS FLOATING AFTER RINSING. IT APPEARS TO BE A PIECE OF THE ANCHORING PLATE THAT BROKE DURING IMPACTION, EVEN THOUGH THE SURGICAL TECHNIQUE WAS FOLLOWED CORRECTLY. THERE WAS NO PATIENT IMPACT AND THE ANCHORING PLATE REMAINS IMPLANTED; THE SURGEON WAS ABLE TO RETRIEVE THE SMALL PIECE OF METAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873229 ↗MalfunctionDec 3, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A SURGERY TO EXTEND A CONSTRUCT, WHILE PUTTING THE ANCHORING PLATE IN, AN ROI-C IMPLANT BROKE WHERE IT CONNECTS TO THE INSERTER. THE SURGERY WAS COMPLETED WITH ANOTHER ROI-C IMPLANT WITHOUT ANY PATIENT OR PROCEDURAL COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707083 ↗MalfunctionOct 24, 2025Fracture; Fracture
IT WAS REPORTED THAT INTRA-OPERATIVELY, THE HOOK OF THE ROI-C INSERTER BROKE OFF AND REMAINED ATTACHED TO THE CAGE SLOT, RESULTING IN ITS RETENTION INSIDE THE BODY. AS A RESULT, BOTH THE CAGE AND THE BLADE WERE REMOVED. THERE WAS A 30 MINUTE DELAY ASSOCIATED WITH THIS EVENT, BUT NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23381133 ↗MalfunctionSep 18, 2025Fracture; Fracture
IT WAS REPORTED THAT AN ROI-C ANCHORING PLATE WAS DEFORMED AND AN ROI-C CAGE FRACTURED DURING SURGERY. A SECOND PLATE AND CAGE WERE USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 20 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23088579 ↗MalfunctionSep 4, 2025Fracture; Fracture
IT WAS REPORTED THAT TWO ROI-C CAGES FRACTURED INTRA-OPERATIVELY AT C6/7 WHILE IMPLANTING THE SUPERIOR PLATES BEFORE LOCKING. THE PLATES WERE MISALIGNED DESPITE USING THE AWL SUCCESSFULLY. THE LEVEL ABOVE HAD A PREVIOUS PLATE/SCREW CONSTRUCT AND THE PROCEDURE WAS AN EXTENSION OF THE PREVIOUSLY SUCCESSFUL FUSION. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITIVE PRODUCT. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 60 MINUTE DELAY. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964512 ↗MalfunctionSep 4, 2025Fracture; Fracture
IT WAS REPORTED THAT TWO ROI-C CAGES FRACTURED INTRA-OPERATIVELY AT C6/7 WHILE IMPLANTING THE SUPERIOR PLATES BEFORE LOCKING. THE PLATES WERE MISALIGNED DESPITE USING THE AWL SUCCESSFULLY. THE LEVEL ABOVE HAD A PREVIOUS PLATE/SCREW CONSTRUCT AND THE PROCEDURE WAS AN EXTENSION OF THE PREVIOUSLY SUCCESSFUL FUSION. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITIVE PRODUCT. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 60 MINUTE DELAY. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964498 ↗
Other LDR Spine Usa, Inc. products
All LDR Spine Usa, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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