FDA Adverse Event
Malfunction
Summary report: N
BIO-STRATIS
MDR report key: 830495
·
Received October 20, 2006
Report
- Report Number
- 3004824670-2006-00002
- Event Type
- Malfunction
- Date Received
- October 20, 2006
- Date of Event
- August 26, 2006
- Report Date
- October 20, 2006
- Manufacturer
- SCANDIUS BIOMEDICAL, INC.
- Product Code
- MAI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INITIAL COMPLAINT INFORMATION RECEIVED BY THE MANUFACTURER INDICATED THAT THE PATIENT HAD NOT FOLLOWED THE RECOMMENDED POST-OP REGIMEN. IT WAS REPORTED THAT THE PATIENT WAS NOT WEARING A PROTECTIVE BRACE AT THE TIME OF THE ALLEGED ADVERSE EVENT. SUBSEQUENT INFORMATION RECEIVED BY THE MANUFACTURER ON 10/18/2006, SUGGESTED THAT A DEVICE RELATED ADVERSE EVENT MAY HAVE OCCURRED. THE DEVICE IS UNAVAILABLE FOR EVALUATION SO THE ACTUAL ROLE OF THE DEVICE IN THE EVENT REMAINS UNCERTAIN.
Description of Event or Problem · 1
PATIENT STEPPED OFF CURB AND FELT POP IN LEFT KNEE. AN MRI CONFIRMED FRACTURE OF THE FEMORAL FIXATION DEVICE.
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 | 46 YR | Required Intervention |