MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-29 for INTRAFIX TIBIAL SHEATH FANT/TIB/T (SIZE 8 254601 manufactured by Lifenet.
[354052]
Post op infection. Right knee arthroscopic acl reconstruction w/patellar tendon allograft. Thirteen days later pt was returned to surgery for a right knee arthroscopy with washing and debridement.
Patient Sequence No: 1, Text Type: D, B5
[355543]
Add'l info rec'd from mfr 7/20/04: trending and analysis did not reveal any other infection complaints for the above lot numbers. A review device history records did not reveal any anomalies or problems with the above lot numbers. A review of sterility records was performed and did not find or identify any problems. Package seal testing results were also reviewed and results were within specifications. No evaluation from the reporting facility was provided to depuy mitek. The product was not returned to depuy mitek and therefore co can not provide any root cause analysis. Depuy mitek considers the issue closed at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032005 |
| MDR Report Key | 526421 |
| Date Received | 2004-04-29 |
| Date of Report | 2004-04-29 |
| Date of Event | 2004-03-31 |
| Date Added to Maude | 2004-05-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRAFIX TIBIAL SHEATH |
| Generic Name | ANTERIOR TIBIAL TENDON ALLOGRAFT (#1 OF 4) |
| Product Code | LMO |
| Date Received | 2004-04-29 |
| Model Number | FANT/TIB/T (SIZE 8 |
| Catalog Number | 254601 |
| Lot Number | 0312172 |
| ID Number | * |
| Device Expiration Date | 2008-11-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 515582 |
| Manufacturer | LIFENET |
| Manufacturer Address | 5809 WARD COURT VIRGINIA BEACH VA 23455 US |
| Brand Name | INTRAFIX TAPERED SCREW |
| Generic Name | BONE MULCH SCREW (#2 OF 4) |
| Product Code | HRX |
| Date Received | 2004-04-29 |
| Model Number | 907320 |
| Catalog Number | 254609 |
| Lot Number | 0308220 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 515588 |
| Manufacturer | ARTHROTEK INC. |
| Manufacturer Address | 56 EAST INC.RT WARSAW IN 46581 US |
| Brand Name | INTRAFIX |
| Generic Name | TAPERED SCREW (#3 OF 4) |
| Product Code | HWC |
| Date Received | 2004-04-29 |
| Model Number | 254609 |
| Catalog Number | 254609 |
| Lot Number | 0308220 |
| ID Number | * |
| Device Expiration Date | 2006-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 3 |
| Device Event Key | 515591 |
| Manufacturer | MITEK WORLDWIDE ETHICON, INC. |
| Manufacturer Address | 249 VANDERBILT AVE NORWOOD MA 02062 US |
| Brand Name | INTRAFIX |
| Generic Name | TIBIAL SHEATH (#4 OF 4) |
| Product Code | HWC |
| Date Received | 2004-04-29 |
| Model Number | 254601 |
| Catalog Number | 254601 |
| Lot Number | 0312172 |
| ID Number | * |
| Device Expiration Date | 2006-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 4 |
| Device Event Key | 515595 |
| Manufacturer | MITEK WORLDWIDE ETHICON, INC. |
| Manufacturer Address | 249 VANDERBILT AVE NORWOOD MA 02062 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-04-29 |