MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2004-04-06 for STER TROC LAG SCR 100MM 903211100 manufactured by Depuy Orthopaedics, Inc..
[27459445]
Date sent to fda: 04/05/2004. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[27459446]
Surgery was done on (b)(6) 2004 to remove the trochanteric nail and lag screw and replace it with a biopolar prosthesis. The original trochanteric nail fixation was done (b)(6) 2003 to repair a fractured r. Hip. On (b)(6) 2003 the patient was returned to the o. R. To reposition the migrating lag screw. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2004-00261 |
| MDR Report Key | 5124820 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2004-04-06 |
| Date of Report | 2004-03-17 |
| Date of Event | 2003-03-11 |
| Date Facility Aware | 2004-03-11 |
| Report Date | 2004-03-17 |
| Date Mfgr Received | 2004-03-17 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2015-10-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HANS KUSSEROW, MGR. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727416 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z390-4Z505-4 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STER TROC LAG SCR 100MM |
| Generic Name | TRAUMA FIXATION |
| Product Code | OVZ |
| Date Received | 2004-04-06 |
| Model Number | NA |
| Catalog Number | 903211100 |
| Lot Number | 293716000 |
| ID Number | 14022-36 CORTICAL SCREW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2004-04-06 |