ROI-ARecalls & reported problems across all models
LDR Spine Usa, Inc. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 20 models of ROI-A by LDR Spine Usa, Inc. in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between May 28, 2019 and Jun 4, 2026 — classified as 6 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Fracture” (22 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-A problems
Device problems
- Fracture22
- Break4
- Positioning Problem4
- Migration3
- Crack2
- Detachment of Device or Device Component2
- Difficult to Advance2
- Difficult to Insert2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Information4
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient3
- No Code Available2
- Pain2
- Bone Fracture(s)1
- Inadequate Osseointegration1
ROI-A models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ROI-A IR2008TSpinal Vertebral Body Replacement Device12 reports
- ROI-A IR2007TSpinal Vertebral Body Replacement Device3 reports
- ROI-A IR2422PSpinal Vertebral Body Replacement Device3 reports
- ROI-A IR2541PSpinal Vertebral Body Replacement Device3 reports
- ROI-A IR2641PIntervertebral Fusion Device With Integrated Fixation, Lumbar3 reports
- ROI-A IR2009TSpinal Vertebral Body Replacement Device2 reports
- ROI-A IR2433PSpinal Vertebral Body Replacement Device2 reports
- ROI-A IR2624PIntervertebral Fusion Device With Integrated Fixation, Lumbar2 reports
- ROI-A IR9280RIntervertebral Fusion Device With Integrated Fixation, Lumbar2 reports
- ROI-A IR2522PSpinal Vertebral Body Replacement Device1 report
- ROI-A IR2532PIntervertebral Fusion Device With Integrated Fixation, Lumbar1 report
- ROI-A IR2543PIntervertebral Fusion Device With Integrated Fixation, Lumbar1 report
- ROI-A IR2632PIntervertebral Fusion Device With Integrated Fixation, Lumbar1 report
- ROI-A IR2634PIntervertebral Fusion Device With Integrated Fixation, Lumbar1 report
- ROI-A IR2733PIntervertebral Fusion Device With Integrated Fixation, Lumbar1 report
- ROI-A IR2741PIntervertebral Fusion Device With Integrated Fixation, Lumbar1 report
- ROI-A IR5243PIntervertebral Fusion Device With Integrated Fixation, Lumbar1 report
- ROI-A IR5245PIntervertebral Fusion Device With Integrated Fixation, Lumbar1 report
- ROI-A IR5332PIntervertebral Fusion Device With Integrated Fixation, Lumbar1 report
- ROI-A IR5341PIntervertebral Fusion Device With Integrated Fixation, Lumbar1 report
Recent ROI-A adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2026Fracture
IT WAS REPORTED THAT A ROI-A ANCHORING PLATE FRACTURED AT S1 INTRA-OPERATIVELY AND REMAINS IMPLANTED. THE PATIENT IS IN STABLE CONDITION AND UNDER CLINICAL FOLLOW-UP WITHOUT EVIDENCE OF SPACER MIGRATION. NO INTERVENTION IS CURRENTLY PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25400354 ↗MalfunctionJun 4, 2026Fracture
IT WAS REPORTED THAT A ROI-A PLATE FRACTURED AT S1 INTRA-OPERATIVELY AND REMAINS IMPLANTED. THE PATIENT IS STABLE AND IS UNDER CLINICAL FOLLOW-UP WITH NO EVIDENCE OF SPACER MIGRATION AT THIS TIME. NO INTERVENTION IS CURRENTLY PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399879 ↗InjuryOct 31, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT HAD A RETURN OF PAIN IN THE LOWER SPINE AND RADIATING DOWN THE LEGS THREE MONTHS POST-OPERATIVELY. ADDITIONAL PAIN MEDICATION DID NOT IMPROVE THE PATIENT'S SYMPTOMS. A FOLLOW-UP RADIOLOGICAL STUDY SHOWED FINDINGS CONSISTENT WITH PSEUDOARTHROSIS, SEGMENTAL VERTEBRAL INSTABILITY, AND CAGE DISPLACEMENT AT THE SURGICAL SITE (L4/L5 SEGMENT). ADDITIONALLY, AN ANCHORING PLATE WAS FRACTURED. A REVISION SURGERY WAS PERFORMED TO ADD A TWO-LEVEL POSTERIOR MIS SCREW CONSTRUCT TO L4/L5. THE IMPLANT WILL NOT BE REMOVED, AND THE PATIENT IS NOW DOING WELL AND WITHOUT PAIN. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: Inadequate Osseointegration; Neuralgia; Pain
MAUDE report 23438057 ↗MalfunctionMay 28, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT INTRA-OPERATIVELY, AN ROI-A PLATE WAS DIFFICULT TO INSERT, AND THIS RESULTED IN THE ROI-A CAGE FRACTURING IN THE DISC SPACE. THE IMPLANTS WERE REMOVED AND ANOTHER CAGE WAS INSTALLED WITHOUT FURTHER COMPLICATIONS. THERE WAS NO PATIENT HARM, BUT THIS DID RESULT IN A PROCEDURAL DELAY OF UNSPECIFIED LENGTH. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22097904 ↗MalfunctionMay 28, 2025Fracture; Fracture
IT WAS REPORTED THAT INTRA-OPERATIVELY, AN ROI-A PLATE WAS DIFFICULT TO INSERT, AND THIS RESULTED IN THE ROI-A CAGE FRACTURING IN THE DISC SPACE. THE IMPLANTS WERE REMOVED AND ANOTHER CAGE WAS INSTALLED WITHOUT FURTHER COMPLICATIONS. THERE WAS NO PATIENT HARM, BUT THIS DID RESULT IN A PROCEDURAL DELAY OF UNSPECIFIED LENGTH. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22097891 ↗MalfunctionMay 2, 2025Fracture; Fracture
IT WAS REPORTED THAT A ROI-A ANCHORING PLATE M FRACTURED POST-OPERATIVELY. THE BREAKAGE WAS DISCOVERED VIA X-RAY DURING A FOLLOW-UP VISIT. THE PATIENT WAS PAIN FREE AND HAD NO COMPLAINTS; THERE WAS NO REPORT OF A FALL OR OTHER ISSUES TO CAUSE THE FRACTURE. IT IS CURRENTLY UNKNOWN IF A REVISION SURGERY IS PLANNED OR NOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21954509 ↗MalfunctionMay 2, 2025Fracture; Fracture
IT WAS REPORTED THAT A ROI-A ANCHORING PLATE M FRACTURED POST-OPERATIVELY. THIS WAS DISCOVERED DURING A FOLLOW-UP VISIT VIA X-RAY. THE PATIENT WAS PAIN FREE AND HAD NO COMPLAINTS; THERE WAS NO REPORT OF A FALL OR OTHER ISSUES TO CAUSE THE FRACTURE. IT IS CURRENTLY UNKNOWN WHETHER OR NOT A REVISION WILL BE PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21953759 ↗MalfunctionFeb 7, 2025Fracture; Fracture
IT WAS REPORTED THAT AN ROI-A CAGE FRACTURED AT THE INSERTION POINT WITH ITS HANDLE DURING IMPACTION. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21333641 ↗MalfunctionApr 25, 2024Fracture; Fracture
IT WAS REPORTED THAT A ROI-A CAGE AND A ROI-A ANCHOR PLATE FRACTURED INTRA-OPERATIVELY. THERE WAS NO REPORTED PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19186251 ↗MalfunctionApr 25, 2024Fracture; Fracture
IT WAS REPORTED THAT A ROI-A CAGE AND A ROI-A ANCHOR PLATE FRACTURED INTRA-OPERATIVELY. THERE WAS NO REPORTED PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19183238 ↗MalfunctionDec 19, 2023Fracture; Fracture
IT WAS REPORTED AN ROI-A CAGE FRACTURED DURING IMPLANTATION. THE SURGEON ELECTED TO LEAVE THE CAGE IMPLANTED. THERE WERE NO REPORTED PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18356978 ↗MalfunctionDec 11, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE SECOND ANCHORING PLATE OF AN ROI-A CONSTRUCT COULD NOT BE INSTALLED BECAUSE THE PATIENT HAD HARD BONE AND AN AWL WAS NOT AVAILABLE TO CREATE THE PILOT HOLE FOR THE PLATE. THERE WERE NO PATIENT IMPACTS REPORTED, BUT THE SURGEON WAS NOT SATISFIED WITH THE CONSTRUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301728 ↗InjuryNov 17, 2023Migration; Migration
IT WAS REPORTED THAT THE THREADS OF AN ROI-A CAGE INSERTER WERE DAMAGED AND WOULD NOT ATTACH TO A CAGE. A SECOND CAGE WAS OPENED TO CONFIRM THE PROBLEM WAS WITH THE THREADS OF THE INSERTER. THEREFORE, THE SURGEON DECIDED TO PLACE THE IMPLANT WITHOUT THE INSERTER. THEN THE CAGE DISCREETLY RECEDED WHEN THE ANCHORING PLATES WERE INSTALLED, CAUSING A POSSIBLE CONFLICT ON THE NERVE ROOT IN THE FORAMEN. THE PATIENT HAD NUMBNESS IN HER RIGHT LEG THE DAY AFTER SURGERY WHICH CONTINUED AFTER HER DISCHARGE FROM THE HOSPITAL, BUT SHE DID NOT LOSE MOTOR FUNCTION. THERE WAS A DELAY OF ABOUT 45 MINUTES TO THE PROCEDURE.
Patient problems: Numbness
MAUDE report 18162106 ↗MalfunctionNov 10, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT AN ROI-A CAGE BROKE WHILE THE ANCHORING PLATE WAS BEING IMPACTED THROUGH IT INTRA-OPERATIVELY. THE ANCHORING PLATE WAS ALSO DAMAGED AND COULD NOT BE USED. THE SURGEON DID USE THE AWL TO PREPARE THE PATIENT'S BONE PRIOR TO INSTALLING THE ANCHORING PLATE. THE CAGE AND PLATE WERE REMOVED AND REPLACED WITH ANOTHER CAGE OF A DIFFERENT SIZE AND ANOTHER PLATE TO COMPLETE THE SURGERY. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18111797 ↗MalfunctionNov 10, 2023Fracture; Fracture
IT WAS REPORTED THAT AN ROI-A CAGE BROKE WHILE THE ANCHORING PLATE WAS BEING IMPACTED THROUGH IT INTRA-OPERATIVELY. THE ANCHORING PLATE WAS ALSO DAMAGED AND COULD NOT BE USED. THE SURGEON DID USE THE AWL TO PREPARE THE PATIENT'S BONE PRIOR TO INSTALLING THE ANCHORING PLATE. THE CAGE AND PLATE WERE REMOVED AND REPLACED WITH ANOTHER CAGE OF A DIFFERENT SIZE AND ANOTHER PLATE TO COMPLETE THE SURGERY. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18111768 ↗
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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