MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1998-06-25 for MANDIBLE DISTRACTOR/WITH RIGHT FOOT 287.953 manufactured by Synthes (usa).
[7782481]
A2, b7; this info was received via a letter from dr. Westermark. H6: the subject device appears to function properly. The cause of this incident cannot be reliably determined.
Patient Sequence No: 1, Text Type: N, H10
[19242628]
The subject was implanted and manually distracted on a daily basis. Over a period of approximately two months, the device continously retracted to its original position. A reoperation was performed and the device was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530088-1998-00012 |
| MDR Report Key | 174595 |
| Report Source | 01,05 |
| Date Received | 1998-06-25 |
| Date of Report | 1998-06-23 |
| Date of Event | 1998-02-01 |
| Date Mfgr Received | 1998-05-27 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 1998-07-01 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANDIBLE DISTRACTOR/WITH RIGHT FOOT |
| Generic Name | MANDIBLE DISTRACTOR |
| Product Code | MON |
| Date Received | 1998-06-25 |
| Model Number | NA |
| Catalog Number | 287.953 |
| Lot Number | A4GD442 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 169749 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1690 RUSSELL ROAD PAOLI PA 19301 US |
| Baseline Brand Name | MANDIBLE DISTRACTOR/RIGHT |
| Baseline Generic Name | MANDIBLE DISTRACTOR |
| Baseline Model No | NA |
| Baseline Catalog No | 287.953 |
| Baseline ID | NA |
| Baseline Device Family | MANDIBLE DISTRACTOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K962272 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-06-25 |