FDA Adverse Event
Injury
Summary report: N
VARITRAX STERNAL CIRCUMFIXATOR¿ SYSTEM
MDR report key: 24413674
·
Received February 23, 2026
Report
- Report Number
- 3027404764-2026-00001
- Event Type
- Injury
- Date Received
- February 23, 2026
- Date of Event
- January 23, 2026
- Report Date
- January 23, 2026
- Manufacturer
- CIRCUMFIX SOLUTIONS INC
- Product Code
- JDQ
- UDI-DI
- 00850049938037
- PMA / PMN Number
- K232986
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE PATIENT'S PHYSICAL CONDITION, ADVANCED CORONARY ARTERY DISEASE, DIABETES, MORBID OBESITY, LIKELY CONTRIBUTED TO THE ISSUE.
Description of Event or Problem · 0
APPROXIMATELY 10 MONTH AFTER INITIAL SURGERY (INITIAL SURGERY DATE (B)(6) 2025), THE PATIENT RETURNED COMPLAINING OF CHEST WALL PAIN. SURGICAL TEAM EXAM DETERMINED NON-UNION OF STERNUM. REVISION SURGERY WAS PERFORMED AND DISCOVERED THAT BANDS WERE BROKE. DEVICE WAS REMOVED AND DEVICE FROM A DIFFERENT MANUFACTURER WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475395 | VARITRAX STERNAL CIRCUMFIXATOR¿ SYSTEM | VARITRAX STERNAL CIRCUMFIXATOR¿ SET | JDQ | CIRCUMFIX SOLUTIONS INC | CFSK-0166 | 142-25-02 | 00850049938037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Required Intervention |