MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-01-10 for BOSKER TMI-SYSTEM UNK manufactured by Medical Research B V.
[145512]
In 1993, pt had bosker tmi implanted. On 12/07/99 pt's spouse reported that the implant had broken. Revision is schduled in 2000. Revision is to include bone graft(s) and dental implant(s).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1032347-2000-00001 |
| MDR Report Key | 258433 |
| Report Source | 00 |
| Date Received | 2000-01-10 |
| Date of Report | 2000-01-10 |
| Date of Event | 1999-12-07 |
| Date Mfgr Received | 1999-12-07 |
| Date Added to Maude | 2000-01-14 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SHERYL MALMBERG |
| Manufacturer Street | 1520 TRADEPORT DR |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| 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 | BOSKER TMI-SYSTEM |
| Generic Name | TRANSMANDIBULAR IMPLANT PROSTHESIS |
| Product Code | MPL |
| Date Received | 2000-01-10 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 250260 |
| Manufacturer | MEDICAL RESEARCH B V |
| Manufacturer Address | VAN SWIETENLAAN 25 NX GRONINGEN NL 9728 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-01-10 |