IJS IJS-E Base Plate AssemblyRecalls & reported problems
Skeletal Dynamics L.L.C. · IJS-E Base Plate Assembly · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Skeletal Dynamics IJS-E base plate assembly is part of an internal joint stabilizer implant used in the elbow. Reports mostly describe the implant coming apart after surgery — screws backing out, the arm joint uncoupling, and the plate or rod breaking — often within weeks, sometimes requiring more surgery. There are 27 reports, with2 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00841506104904), received between Jul 20, 2020 and Jul 30, 2026 — classified as 3 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component14
- Fracture9
- Mechanical Problem4
- Off-Label Use3
- Installation-Related Problem2
- Break1
- Improper or Incorrect Procedure or Method1
- Unintended Movement1
Patient problems
- Failure of Implant23
- Joint Laxity9
- Subluxation2
- Foreign Body In Patient1
- Joint Dislocation1
- Laceration(s)1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Detachment of Device or Device Component
An implanted IJS-E (Internal Joint Stabilizer - Elbow) uncoupled at the arm joint (the Proximal Locking Screw backed out) two months following initial implantation, requiring removal surgery.
Patient problems: Failure of Implant
MAUDE report 50091594 ↗MalfunctionDec 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE AXIS PIN BACKED OUT OF A PATIENT'S IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) CONSTRUCT AFTER 15 WEEKS, REQUIRING ADDITIONAL SURGERY.
Patient problems: Failure of Implant
MAUDE report 23733230 ↗MalfunctionNov 24, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
A PATIENT EXPERIENCED REPEATED ISSUES WITH IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) CONSTRUCTS WITHIN 2-3 WEEKS OF INITIAL IMPLANTATION, INCLUDING BREAKAGE OF THE DISTAL CONNECTING ROD AND UNCOUPLING AT THE ARM JOINT (THE PROXIMAL LOCKING SCREW BACKED OUT).
Patient problems: Failure of Implant
MAUDE report 23631012 ↗MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) UNCOUPLED AT THE ARM JOINT (THE PROXIMAL LOCKING SCREW BACKED OUT) ONE WEEK FOLLOWING INITIAL IMPLANTATION, REQUIRING REVISION SURGERY.
Patient problems: Failure of Implant
MAUDE report 22980564 ↗MalfunctionOct 18, 2024Unintended Movement; Unintended Movement
AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER: ELBOW) FAILED AT THE BASE PLATE ROD FOUR MONTHS AFTER INITIAL IMPLANTATION.
Patient problems: Failure of Implant
MAUDE report 20487182 ↗MalfunctionJun 28, 2024Fracture; Fracture
AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) BROKE AT THE AXIS PIN EYELET TWO WEEKS FOLLOWING INITIAL IMPLANTATION.
Patient problems: Failure of Implant
MAUDE report 19637858 ↗MalfunctionMay 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) UNCOUPLED AT THE ARM JOINT (THE PROXIMAL LOCKING SCREW BACKED OUT) IN THE WEEKS FOLLOWING SURGERY.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 19240048 ↗MalfunctionApr 11, 2024Fracture; Fracture
AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) BROKE AT THE BASE OF THE BOOM ARM FOUR WEEKS AFTER INITIAL IMPLANTATION.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 19092955 ↗MalfunctionApr 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) UNCOUPLED AT THE ARM JOINT.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 19047820 ↗MalfunctionMar 22, 2024Fracture; Fracture
AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) BROKE AT THE BASE OF THE BOOM ARM ONE WEEK AFTER INITIAL IMPLANTATION.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 18958819 ↗MalfunctionMar 20, 2024Fracture; Fracture
AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) BROKE AT THE AXIS PIN EYELET THREE MONTHS AFTER INITIAL IMPLANTATION.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 18944730 ↗MalfunctionDec 20, 2023Fracture; Fracture
AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) BROKE AT THE BASE OF THE BOOM ARM SIX DAYS AFTER INITIAL IMPLANTATION.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 18365232 ↗MalfunctionNov 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) UNCOUPLED AT THE ARM JOINT IN THE WEEKS FOLLOWING SURGERY.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 18085043 ↗MalfunctionJun 8, 2023Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component
AN IMPLANTED IJS-E (INTERNAL JOINT STABILIZER - ELBOW) UNCOUPLED AT THE ARM JUNCTION IN THE WEEKS FOLLOWING SURGERY. THIS PATIENT HAS A HISTORY OF SURGICAL COMPLICATIONS.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 17090373 ↗MalfunctionMay 1, 2023Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component
A SURGEON IMPLANTED TWO INTERNAL ELBOW JOINT STABILIZERS STACKED ON TOP OF EACH OTHER AND BOTH AXIS PINS LOOSENED.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 16850564 ↗MalfunctionJan 27, 2023Mechanical Problem; Detachment of Device or Device Component; Installation-Related Problem; Mechanical Problem; Detachment of Device or Device Component; Installation-Related Problem
IJS-E IMPLANT DISASSEMBLED ABOUT 2 WEEKS POST-OP.
Patient problems: Failure of Implant; Joint Laxity; Laceration(s)
MAUDE report 16254875 ↗MalfunctionJan 6, 2023Mechanical Problem; Mechanical Problem
IJS-E DEVICE DISASSEMBLED 5 WEEKS POST-IMPLANTATION. DISTAL LOCKING SCREW BACKED OUT OF THE LOCKING JOINT.
Patient problems: Failure of Implant
MAUDE report 16118130 ↗MalfunctionNov 7, 2022Mechanical Problem; Mechanical Problem
PROXIMAL CONNECTING ROD OF IJS-E STABILIZER BROKE AT THE CLAMP. PATIENT HAD RHEUMATOID ARTHRITIS AND DID NOT HEAL PROPERLY. X-RAYS WERE TAKEN 6 MONTHS POST-OP.
Patient problems: Failure of Implant
MAUDE report 15748999 ↗MalfunctionNov 7, 2022Mechanical Problem; Mechanical Problem
DISTAL CONNECTING ROD OF IJS-E STABILIZER BROKE 6 MONTHS POST-OP. PATIENT IS A FEMALE 5'4 220 LBS.
Patient problems: Failure of Implant
MAUDE report 15747172 ↗MalfunctionJul 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
DR. (B)(6) PERFORMED X-RAYS ABOUT A MONTH POST-IMPLANTATION AND FOUND THAT THE CONNECTING SCREW OF THE IJS-E IMPLANT HAD BACKED OUT AND MIGRATED DISTALLY UNDER THE OLECRANON. THIS SCREW IS A COMPONENT OF THE IMPLANT WHICH SECURES BOTH CONNECTING RODS TO EACH OTHER AND IS NOT INSTALLED INTO BONE. THE SURGEON HAS DECIDED TO LEAVE THE IMPLANT AS IS AND IMMOBILIZE THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 15070153 ↗MalfunctionApr 12, 2022Installation-Related Problem; Installation-Related Problem
SURGEON IDENTIFIED LOOSE IJS CONSTRUCT 10 DAYS POST IMPLANTATION.
Patient problems: Failure of Implant
MAUDE report 14091181 ↗MalfunctionFeb 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
PATIENT COMPLAINED OF PAIN TWELVE MONTHS AFTER IMPLANTATION OF THE IJS-E IMPLANT. DOCTOR CONFIRMED VIA X-RAY THAT THE IMPLANT HAD DISASSEMBLED.
Patient problems: Pain
MAUDE report 13457778 ↗MalfunctionOct 22, 2020Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component
InjuryOct 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
InjurySep 24, 2020Break; Off-Label Use; Break; Off-Label Use
Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE devices
- LOCK SCREW SQUARE DRIVE 131827118Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE1 recall0 reports
- LOCK SCREW SQUARE DRIVE 131827120Biomet Orthopedics, LLC · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE1 recall0 reports
- NA 390.008Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE21 reports
- NA 294.56Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- NA 390.003Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- NA 394.85Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE8 reports
- TRUE/LOK MONOLATERAL/BILATERAL FIXATOR 1Orthofix Srl · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite6 reports
- NA 390.051Synthes GmbH · APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE6 reports
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 14, 2026 · each report above links to its original FDA record
- 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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