MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2003-08-01 for MANDIBLE DISTRACTOR/SINGLE VECTOR 287.954 manufactured by Synthes (usa).
[300609]
A distractor appeared to not be advancing and was removed from the pt. Upon removal, surgeon found the distractor to be working as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530088-2003-00013 |
| MDR Report Key | 475285 |
| Report Source | 05,07 |
| Date Received | 2003-08-01 |
| Date of Report | 2003-07-07 |
| Date of Event | 2003-07-07 |
| Date Mfgr Received | 2003-07-07 |
| Device Manufacturer Date | 1997-07-01 |
| Date Added to Maude | 2003-08-05 |
| 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 | JODI TEMPLE |
| Manufacturer Street | 1690 RUSSELL ROAD |
| Manufacturer City | PAOLI PA 19301 |
| Manufacturer Country | US |
| Manufacturer Postal | 19301 |
| Manufacturer Phone | 6106479700 |
| Manufacturer G1 | SYNTHE, USA |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANDIBLE DISTRACTOR/SINGLE VECTOR |
| Generic Name | MANDIBLE DISTRACTOR |
| Product Code | MON |
| Date Received | 2003-08-01 |
| Returned To Mfg | 2003-07-28 |
| Model Number | NA |
| Catalog Number | 287.954 |
| Lot Number | A4GG741 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 464138 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1690 RUSSELL ROAD PAOLI PA 19301 US |
| Baseline Brand Name | MANDIBLE DISTRACTOR (MAXILLOFACIAL) |
| Baseline Generic Name | MANDIBLE DISTRACTOR |
| Baseline Model No | NA |
| Baseline Catalog No | 287.954 |
| 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 | 2003-08-01 |