General instrumentationRecalls & reported problems across all models
LDR Spine Usa, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 0
We found 9 models of General instrumentation by LDR Spine Usa, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between May 10, 2021 and Feb 13, 2026 — classified as 14 injuries, 15 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 General instrumentation problems
Device problems
- Fracture22
- Device Dislodged or Dislocated7
- Material Twisted/Bent3
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Hemorrhage/Blood Loss/Bleeding6
- Perforation of Vessels6
- Foreign Body In Patient5
- Insufficient Information2
- Spinal Column Injury2
- Numbness1
- Pain1
General instrumentation models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- General instrumentation IG008ROrthopedic Manual Surgical Instrument20 reports
- General instrumentation IG021RForceps, General & Plastic Surgery2 reports
- General instrumentation IG007RRetractor1 report
- General instrumentation IG018ROrthopedic Manual Surgical Instrument1 report
- General instrumentation IG022ROrthopedic Manual Surgical Instrument1 report
- General instrumentation IG023ROrthopedic Manual Surgical Instrument1 report
- General instrumentation IG024ROrthopedic Manual Surgical Instrument1 report
- General instrumentation IG025ROrthopedic Manual Surgical Instrument1 report
- General instrumentation IG026ROrthopedic Manual Surgical Instrument1 report
Recent General instrumentation adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT INTRA-OPERATIVE PROBLEMS WITH A DISTRACTOR LED TO A VEIN RUPTURING, CAUSING THE PATIENT TO BLEED HEAVILY. THE DISTRACTOR BLADES DETACHED FROM THE DISTRACTOR BODY AND WERE LEFT IN THE WOUND; THEY WERE ABLE TO BE RETRIEVED. THE DISTRACTOR'S ADJUSTMENT KNOB WAS ALSO BENT SO THE DISTRACTOR WAS STUCK IN ITS POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS IN STABLE CONDITION AFTER A ONE-HOUR DELAY. THIS IS REPORT SIX OF SIX FOR THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 24335747 ↗InjuryFeb 13, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT INTRA-OPERATIVE PROBLEMS WITH A DISTRACTOR LED TO A VEIN RUPTURING, CAUSING THE PATIENT TO BLEED HEAVILY. THE DISTRACTOR BLADES DETACHED FROM THE DISTRACTOR BODY AND WERE LEFT IN THE WOUND; THEY WERE ABLE TO BE RETRIEVED. THE DISTRACTOR'S ADJUSTMENT KNOB WAS ALSO BENT SO THE DISTRACTOR WAS STUCK IN ITS POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS IN STABLE CONDITION AFTER A ONE-HOUR DELAY.THIS IS REPORT FIVE OF SIX FOR THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 24334931 ↗InjuryFeb 13, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT INTRA-OPERATIVE PROBLEMS WITH A DISTRACTOR LED TO A VEIN RUPTURING, CAUSING THE PATIENT TO BLEED HEAVILY. THE DISTRACTOR BLADES DETACHED FROM THE DISTRACTOR BODY AND WERE LEFT IN THE WOUND; THEY WERE ABLE TO BE RETRIEVED. THE DISTRACTOR'S ADJUSTMENT KNOB WAS ALSO BENT SO THE DISTRACTOR WAS STUCK IN ITS POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS IN STABLE CONDITION AFTER A ONE-HOUR DELAY.THIS IS REPORT FOUR OF SIX FOR THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 24334865 ↗InjuryFeb 13, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT INTRA-OPERATIVE PROBLEMS WITH A DISTRACTOR LED TO A VEIN RUPTURING, CAUSING THE PATIENT TO BLEED HEAVILY. THE DISTRACTOR BLADES DETACHED FROM THE DISTRACTOR BODY AND WERE LEFT IN THE WOUND; THEY WERE ABLE TO BE RETRIEVED. THE DISTRACTOR'S ADJUSTMENT KNOB WAS ALSO BENT SO THE DISTRACTOR WAS STUCK IN ITS POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS IN STABLE CONDITION AFTER A ONE-HOUR DELAY. THIS IS REPORT THREE OF SIX FOR THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 24334799 ↗InjuryFeb 13, 2026Device Dislodged or Dislocated; Material Twisted/Bent
IT WAS REPORTED THAT INTRA-OPERATIVE PROBLEMS WITH A DISTRACTOR LED TO A VEIN RUPTURING, CAUSING THE PATIENT TO BLEED HEAVILY. THE DISTRACTOR BLADES DETACHED FROM THE DISTRACTOR BODY AND WERE LEFT IN THE WOUND; THEY WERE ABLE TO BE RETRIEVED. THE DISTRACTOR'S ADJUSTMENT KNOB WAS ALSO BENT SO THE DISTRACTOR WAS STUCK IN ITS POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS IN STABLE CONDITION AFTER A ONE-HOUR DELAY.THIS IS REPORT TWO OF SIX FOR THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 24334632 ↗InjuryFeb 13, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT INTRA-OPERATIVE PROBLEMS WITH A DISTRACTOR LED TO A VEIN RUPTURING, CAUSING THE PATIENT TO BLEED HEAVILY. THE DISTRACTOR BLADES DETACHED FROM THE DISTRACTOR BODY AND WERE LEFT IN THE WOUND; THEY WERE ABLE TO BE RETRIEVED. THE DISTRACTOR'S ADJUSTMENT KNOB WAS ALSO BENT SO THE DISTRACTOR WAS STUCK IN ITS POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS IN STABLE CONDITION AFTER A ONE-HOUR DELAY. THIS IS REPORT ONE OF SIX FOR THIS EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 24334537 ↗MalfunctionDec 22, 2025Fracture; Fracture
IT WAS REPORTED THAT A ROI-C DISTRACTION PIN BROKE INTRA-OPERATIVELY IN THE PATIENT'S VERTEBRAL BODY. THERE WAS A DELAY WITHIN THE PROCEDURE TO DRILL OUT THE TIP OF THE PIN AND THE TIP WAS SUCCESSFULLY REMOVED. THERE WERE NO CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872554 ↗InjuryDec 5, 2025Fracture; Fracture
IT WAS REPORTED THAT A DISTRACTION FORCEPS BROKE WHEN INSERTED INTO THE INTERVERTEBRAL SPACE DURING A DOUBLE LUMBAR LEVEL PROCEDURE. THE BREAK OCCURRED AT THE SECOND LEVEL, AND RESULTED IN THE PROCEDURE BEING ABORTED AND WILL NEED TO BE COMPLETED AT A LATER DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23730151 ↗MalfunctionJul 17, 2025Fracture; Fracture
IT WAS REPORTED THAT A RETRACTOR FIXATION PIN FRACTURED IN THE PATIENT'S VERTEBRA INTRA-OPERATIVELY. ADDITIONAL PATIENT AND CLINICAL INFORMATION IS UNAVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 22532694 ↗MalfunctionJul 17, 2025Fracture; Fracture
IT WAS REPORTED THAT A RETRACTOR FIXATION PIN FRACTURED IN THE PATIENT'S VERTEBRA INTRA-OPERATIVELY. THE SURGEON WAS ABLE TO RETRIEVE IT AND THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22532606 ↗MalfunctionJun 12, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A DISTRACTION PIN FRACTURED INSIDE A PATIENT INTRA-OPERATIVELY, BUT WAS SUBSEQUENTLY REMOVED, AND THE SURGERY WAS COMPLETED USING A SPARE PIN WITHOUT THE INCIDENT LEADING TO ANY PATIENT HARM OR PROCEDURAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22198100 ↗MalfunctionApr 3, 2025Fracture; Fracture
IT WAS REPORTED THAT A RETRACTOR FIXATION PIN FRACTURED INTRA-OPERATIVELY AT C4. THERE WAS A 20 MINUTE PROCEDURAL DELAY WHILE THE SURGEON REMOVED PART OF THE VERTEBRAL BODY TO A DEPTH OF 4 MM TO BE ABLE TO GRIP THE END OF THE FRACTURED PIECE AND REMOVE IT. POST-OPERATIVE MONITORING IS IN PLACE FOR A LOW RISK OF VERTEBRAL BODY FRACTURE AND BONE BLEEDING.
Patient problems: Spinal Column Injury
MAUDE report 21763386 ↗InjuryMar 11, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A CERVICAL ARTHRODESIS PROCEDURE USING ROI-C EQUIPMENT, A DISTRACTION PIN BROKE OFF IN THE PATIENT'S VERTEBRAL BODY, AND THE FRACTURED PIECE WAS RETAINED. THE SURGERY WAS NOT DELAYED, AND THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 21573788 ↗MalfunctionMar 7, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF A MOBI-C RETRACTOR FIXATION PIN FRACTURED DURING SURGERY. THE SURGEON WAS ABLE TO RETRIEVE THE PIN AND A RESERVE PIN WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21549648 ↗MalfunctionFeb 18, 2025Fracture; Fracture
IT WAS REPORTED THAT A RETRACTOR FIXATION PIN FRACTURED INTRA-OPERATIVELY. THE THREADED PORTION OF THE PIN WAS RETRIEVED FROM THE VERTEBRAL BODY USING A TREPHINE. NO FRAGMENTS WERE RETAINED BY THE PATIENT AND THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21403145 ↗
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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