MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-08-07 for OBWEGESER INTERDENTAL OSTEOTOME, 6.5MM, 15.5CM 01-17847 manufactured by Stryker Osteosynthesis Freiburg.
[1173693]
Surgeon was chiseling around the sagittal plane and a piece of the osteotome splintered off into the pt. The surgeon was able to recover the piece of the osteotome.
Patient Sequence No: 1, Text Type: D, B5
[8372811]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010177-2009-00106 |
| MDR Report Key | 1486432 |
| Report Source | 07 |
| Date Received | 2009-08-07 |
| Date of Report | 2009-07-08 |
| Date of Event | 2009-07-07 |
| Date Mfgr Received | 2009-07-08 |
| Date Added to Maude | 2010-06-08 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROB YAMASHITA |
| Manufacturer Street | 750 TRADE CENTRE WAY SUITE 200 |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693245346 |
| Manufacturer G1 | STRYKER OSTEOSYNTHESIS FREIBURG |
| Manufacturer Street | BOTZINGER STRASSE 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OBWEGESER INTERDENTAL OSTEOTOME, 6.5MM, 15.5CM |
| Generic Name | INSTRUMENT |
| Product Code | EMM |
| Date Received | 2009-08-07 |
| Model Number | NA |
| Catalog Number | 01-17847 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER OSTEOSYNTHESIS FREIBURG |
| Manufacturer Address | FREIBURG D-79111 GM D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-08-07 |