FDA Adverse Event
Injury
Summary report: N
RIGIDFIS 3.3 MM ST CROSS PIN
MDR report key: 2080625
·
Received April 25, 2011
Report
- Report Number
- 1221934-2011-00154
- Event Type
- Injury
- Date Received
- April 25, 2011
- Date of Event
- April 7, 2011
- Report Date
- April 8, 2011
- Manufacturer
- DEPUY MITEK
- Product Code
- MBI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A F/U REPORT.
Description of Event or Problem · 1
THE ACL WAS PERFORMED IN (B)(6) 2009. THE PT COMPLAINED IN (B)(6) 2011 OF SEVERE KNEE PAIN. THE MRI CONFIRMED A LOOSE BODY. YESTERDAY, A KNEE ARTHROSCOPY WAS PERFORMED AND A SMALL PIECE OF THE RIGIDFIX IMPLANT WAS REMOVED FROM THE KNEE JOINT. THE ACL AND THE KNEE DID NOT REQUIRE ADD'L PROCEDURES. NOTHING BEING RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIGIDFIS 3.3 MM ST CROSS PIN | SOFT TISSUE FIXATION DEVICE | MBI | DEPUY MITEK | 210133 | 3254199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |