MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-10-24 for INBONE SAW GUIDE 40001 manufactured by Inbone Technologies.
[735596]
Saw guide retainer became separated from post during procedure.
Patient Sequence No: 1, Text Type: D, B5
[8114071]
Confirmed report of saw guide retainer separating from saw guide post. Determined vibration during use caused separation. Implemented engineering design change to address issue. Add'l catalog # 50028.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005663955-2007-00005 |
| MDR Report Key | 932178 |
| Report Source | 07 |
| Date Received | 2007-10-24 |
| Date of Report | 2007-10-24 |
| Date of Event | 2007-07-25 |
| Date Mfgr Received | 2007-07-25 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2007-12-17 |
| 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 | BILL MYERS |
| Manufacturer Street | 4820 N. 63RD ST. STE. 104 |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3038655105 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INBONE SAW GUIDE |
| Generic Name | SAW GUIDE |
| Product Code | DWI |
| Date Received | 2007-10-24 |
| Returned To Mfg | 2007-07-31 |
| Model Number | NA |
| Catalog Number | 40001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 910727 |
| Manufacturer | INBONE TECHNOLOGIES |
| Manufacturer Address | 4820 N. 63RD ST. STE. 104 BOULDER CO 80301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-24 |