FDA Adverse Event
Injury
Summary report: N
ALM ORTHO TRANSTIBIAL BONE ANCHORED OSSEOINTEGATED IMPLANT
MDR report key: 23861047
·
Received December 21, 2025
Report
- Report Number
- 3029890418-2025-00003
- Event Type
- Injury
- Date Received
- December 21, 2025
- Date of Event
- November 26, 2025
- Report Date
- December 21, 2025
- Manufacturer
- ALM ORTHO, INC
- Product Code
- ISH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A REVIEW OF THE DEVICE HISTORY RECORD DID NOT FIND ANY DESIGN OR MANUFACTURING DEFECTS. FURTHER INVESTIGATION WILL BE COMPLETED UPON RECEIPT OF THE EXPLANTED DEVICE AND PERTINENT FINDINGS WILL BE UPDATED. BASED ON HISTORICAL DATA, THIS HAS BEEN DETERMINED TO BE AN ISOLATED INCIDENT.
Description of Event or Problem · 0
THE DEVICE WAS IMPLANTED ON (B)(6) 2024 WITHOUT INCIDENT. ON (B)(6) 2025 THE COMPANY WAS NOTIFIED BY THE PATIENT'S SURGEON THAT THERE WAS A FRACTURED IMPLANT. THE COMPANY RECEIVED CONFIRMATORY IMAGING OF THE BROKEN IMPLANT WITH IMAGES OF THE DISTAL IMPLANT FRAGMENT ON 11/22/2025. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2477516 | ALM ORTHO TRANSTIBIAL BONE ANCHORED OSSEOINTEGATED IMPLANT | TRANSTIBIAL IMPLANT CUSTOMER DEVICE | ISH | ALM ORTHO, INC | 121823.04A | 256-001-003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Required Intervention |