MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-05-25 for * manufactured by Tontarra Medizintechnik Gmbh.
[16503820]
Conclusion: no definite conclusion for the exact cause can be drawn. Above observations, however, leads us to the assumption, that the jaw part broke off due to overstressing or any kind of impact, when for example the instrument is dropped to the floor, or incautious handling during the cleaning, and sterilization process. Since our production documents indicate compliance with all specs, we feel that no corrective action has to be taken on our part. This incident is classified as not being security relevant as per the guideline of the european union: and it is not subject to be reported to the european authorities, because no pt injury incurred.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680515-2007-00005 |
| MDR Report Key | 976999 |
| Report Source | 08 |
| Date Received | 2007-05-25 |
| Date Mfgr Received | 2007-05-16 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2008-01-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | DAIMLER STRASSE 15 |
| Manufacturer City | WURMLINGEN 78573 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78573 |
| Manufacturer Phone | 461965760 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | KOA |
| Date Received | 2007-05-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 945033 |
| Manufacturer | TONTARRA MEDIZINTECHNIK GMBH |
| Manufacturer Address | DAIMLERSTRASSE 15 WURMLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-25 |