FDA Adverse Event
Injury
Summary report: N
BIO-STRATIS
MDR report key: 936676
·
Received October 31, 2007
Report
- Report Number
- 3004824670-2007-00006
- Event Type
- Injury
- Date Received
- October 31, 2007
- Date of Event
- December 12, 2005
- Report Date
- October 31, 2007
- Manufacturer
- SCANDIUS BIOMEDICAL, INC.
- Product Code
- MAI
- PMA / PMN Number
- K04-1961
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING ACL RECONSTRUCTION SURGERY, THE CROSS-PIN WAS LIKELY TO HAVE BEEN OVER INSERTED, CAUSING THE GRAFT BLOCK IMPLANT TO CRACK. IT IS BELIEVED THAT THE FRACTURED IMPLANT WAS REMOVED, AND REPLACED, AND THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. ALTHOUGH NO PATIENT INJURY WAS REPORTED, A REVIEW OF COMPLAINT FILES INDICATES THAT A LOW PROBABILITY FOR PATIENT INJURY EXISTED. AN MDR IS BEING SUBMITTED AT THIS TIME TO ENSURE FULL COMPLIANCE WITH APPLICABLE REGULATIONS.
Description of Event or Problem · 1
GRAFT BLOCK IMPLANT CRACKED INTRAOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO-STRATIS | ABSORBABLE ACL RECONSTRUCTION SYSTEM | MAI | SCANDIUS BIOMEDICAL, INC. | NA | 1231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |