MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2000-07-12 for ORTHOSORB PIN UNK manufactured by Depuy - Raynham / Div. Of Depuy Orthopaedics, Inc.
[166339]
Report was rec'd from attorney representing pt's podiatrist. Pt has filed malpractice action claiming orthosorb screw surgery caused allergic reaction and an avn (arterial-vasular necrosis).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2000-00183 |
| MDR Report Key | 285268 |
| Report Source | 05,07 |
| Date Received | 2000-07-12 |
| Date of Report | 2000-07-12 |
| Date Facility Aware | 2000-06-14 |
| Report Date | 2000-07-12 |
| Date Mfgr Received | 2000-06-14 |
| Date Added to Maude | 2000-07-13 |
| 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 | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HANS KUSSEROW, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DR |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 2193727416 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHOSORB PIN |
| Generic Name | FIXATION PROSTHESIS |
| Product Code | MBJ |
| Date Received | 2000-07-12 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 276063 |
| Manufacturer | DEPUY - RAYNHAM / DIV. OF DEPUY ORTHOPAEDICS, INC |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-07-12 |