MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-21 for 7MM VERSITOMIC ISI BIOSTEON TAP TG118007ST manufactured by T.a.g. Medical Products Corporation Ltd.
[98012585]
As we were placing the titanium screw into the femur and the physician tightened one last time and the trinkle broke at the proximal end just before the hex driver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043971-2018-00004 |
| MDR Report Key | 7208773 |
| Date Received | 2018-01-21 |
| Date of Report | 2018-01-21 |
| Date Mfgr Received | 2018-01-16 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2018-01-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHLOMI DINES |
| Manufacturer Street | KIBUTZ GAATON |
| Manufacturer City | GAATON, 25130000 |
| Manufacturer Country | IS |
| Manufacturer Postal | 25130000 |
| Manufacturer G1 | T.A.G. MEDICAL PRODUCTS CORPORATION LTD |
| Manufacturer Street | KIBUTZ GAATON |
| Manufacturer City | GAATON, 25130000 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 25130000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 7MM VERSITOMIC ISI BIOSTEON TAP |
| Generic Name | 7MM VERSITOMIC ISI BIOSTEON TAP |
| Product Code | HWK |
| Date Received | 2018-01-21 |
| Model Number | TG118007ST |
| Catalog Number | TG118007ST |
| Lot Number | 14D07 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | T.A.G. MEDICAL PRODUCTS CORPORATION LTD |
| Manufacturer Address | KIBUTZ GAATON GAATON, 25130000 IS 25130000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-21 |