GIRO GROWTH MODULATION SYSTEM
Report
- Report Number
- 3000327445-2025-00001
- Event Type
- Injury
- Date Received
- October 10, 2025
- Date of Event
- February 27, 2025
- Report Date
- October 10, 2025
- Manufacturer
- ORTHOPEDIATRICS CANADA ULC
- Product Code
- OBT
- PMA / PMN Number
- K220190
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
THE SURGEON REPORTED A FAILURE OF THE GIRO IMPLANT, NECESSITATING REVISION SURGERY. THE ONLY AVAILABLE IMAGING IS AN X-RAY FROM THE REVISION PROCEDURE, WHICH SHOWS BENDING OF THE MALE POST AND INSUFFICIENT ENGAGEMENT OF THE THREADED MALE COMPONENT. TO DETERMINE THE ROOT CAUSE OF THESE ISSUES, ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE SURGEON, INCLUDING X-RAYS FROM THE INITIAL IMPLANTATION SURGERY. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR #3000327-2025-00001 ON (B)(6) 2025 BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (B)(4). CAPA INITIATED TO ADDRESS THE ISSUE.
UPDATE - APRIL 9, 2025: FOLLOWING A MEETING WITH THE SURGEON, ADDITIONAL DETAILS WERE OBTAINED: · THE PATIENT WAS A 10-YEAR-OLD CHILD. · THE GIRO CABLES WERE POSITIONED WELL AND HAD EQUAL TENSION ON BOTH SIDES. · THE METAPHYSEAL THREADS OF THE MALE COMPONENT WERE ENGAGED IN THE BONE AT THE TIME OF INITIAL IMPLANTATION. · HOWEVER, THE AMOUNT OF OVERLAP BETWEEN THE MALE AND FEMALE POSTS IN THE CENTRAL REGION WAS INSUFFICIENT. THE SURGEON NOTED THAT GREATER OVERLAP WOULD HAVE IMPROVED THE OVERALL CONSTRUCT STRENGTH. EVEN THOUGH THE MALE POST THREAD WAS INSIDE THE BONE, IT COULD NOT BE FULLY INSERTED DUE TO THE TENSION FROM THE GIRO CABLE AND THE NATURAL FLARE OF THE BONE AT THAT LOCATION. THE CURVED SURFACE OF THE BONE LIMITED FULL ENGAGEMENT OF THE THREADED PORTION OF THE MALE POST. ON THE FIRST FOLLOW-UP X-RAY (3-4 MONTHS POST-SURGERY), IT WAS EVIDENT THAT: · THE AREA OF OVERLAP BETWEEN THE MALE AND FEMALE COMPONENTS WAS SMALL. · THE METAPHYSEAL THREADS OF THE MALE POST WERE BEGINNING TO PULL OUT OF THE BONE. · THE OVERLAP BETWEEN MALE AND FEMALE POSTS CONTINUED TO DECREASE AS THE GROWTH PLATE EXPANDED. · THE INCOMPLETE ENGAGEMENT OF THE MALE POST THREADS ALLOWED THE TENSION FROM THE CABLE TO GRADUALLY PULL THE POST OUT OF THE TIBIA, FURTHER REDUCING THE OVERLAP. AT THE SECOND FOLLOW-UP X-RAY (PRIOR TO THE REVISION SURGERY, IMAGING NOT PROVIDED BUT DESCRIBED BY HE SURGEON): · THE METAPHYSEAL MALE POST ON THE MEDIAL SIDE WAS NEARLY COMPLETELY DISENGAGED, WITH ONLY A SMALL PORTION STILL INSIDE THE BONE. · THERE WAS MINIMAL REMAINING OVERLAP BETWEEN THE MALE AND FEMALE COMPONENTS. BY THE TIME OF THE REVISION PROCEDURE (7 MONTHS POST-IMPLANTATION): · THE X-RAY CONFIRMED BENDING OF THE MALE POST AND INSUFFICIENT ENGAGEMENT OF THE THREADED MALE COMPONENT. · THE SURGEON CHOSE NOT TO REPLACE THE IMPLANT, INSTEAD RE-ENGAGING THE MALE POST AND MAKING CORRECTIVE ADJUSTMENTS TO AVOID ADDITIONAL SURGICAL TRAUMA FOR THE PATIENT. SHE WAS ABLE TO MANUALLY RE-ENGAGE THE POST WITHOUT REPLACING THE ENTIRE IMPLANT ASSEMBLY, OPTING FOR A LESS INVASIVE CORRECTIVE APPROACH SUITABLE FOR PEDIATRIC PATIENTS. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR #3000327-2025-00001 ON MARCH 26, 2025, BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (B)(4). CAPA INITIATED TO ADDRESS THE ISSUE.
THE SURGEON REPORTED A FAILURE OF THE GIRO IMPLANT, REQUIRING REVISION SURGERY. THE ISSUE INVOLVED BENDING OF THE MALE POST AND CONCERNS ABOUT THE ENGAGEMENT OF THE THREADED COMPONENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 315660 | GIRO GROWTH MODULATION SYSTEM | PLATE, BONE, GROWTH CONTROL, PEDIATRIC, EPIPHYSIODESIS | OBT | ORTHOPEDIATRICS CANADA ULC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Unknown | Other |