FDA Adverse Event
Injury
Summary report: N
MILAGRO BIORECPLACEABLE INTERFERENCE SCREW
MDR report key: 1132643
·
Received August 22, 2008
Report
- Report Number
- 1221934-2008-00418
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- August 15, 2008
- Report Date
- August 22, 2008
- Manufacturer
- DEPUY MITEK
- Product Code
- MBI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP CONTACT WITH SURGEON INDICATED REVISION SURGERY TO REMOVE THE DEVICES WAS PERFORMED IN 2008. TO DATE THAT IS ALL THE INFORMATION WE RECEIVED. IT HAS BEEN REPORTED THE DEVICES WILL BE RETURNED, BUT AT THIS POINT, IT DOES NOT APPEAR THEY WILL BE RETURNED WITHIN 30 DAYS AS REQUIRED BY THE REGULATION. DEPUY MITEK IS IN THE PROCESSING OF GATHERING MORE INFORMATION ABOUT THE EVENT AND WILL FILE A FOLLOW-UP REPORT WHEN THE DEVICE IS RETURNED FOR EVALUATION.
Description of Event or Problem · 1
A DEPUY MITEK MARKETING EMPLOYEE IS REPORTING A SURGEON TOLD HIM A PATIENT WHO HAD AN ACL PROCEDURE RETURNED WITH SWELLING AND PAIN 7 MONTHS POST-OP. A MILAGRO INTERFERENCE SCREW WAS USED ON THE TIBIAL SIDE. A RIGIDFIX CROSSPIN WAS ALSO USED IN THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILAGRO BIORECPLACEABLE INTERFERENCE SCREW | SOFT TISSUE FIXATION DEVICE | MBI | DEPUY MITEK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |