MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-11 for 7MM VERSITOMIC ISI BIOSTEON TAP TG118007ST manufactured by T.a.g. Medical Products Corporation Ltd.
[97740850]
Flexible 7mm tap broke off into patient as surgeon started to unscrew it after tapping the 28mm line.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043971-2017-00006 |
| MDR Report Key | 7182018 |
| Date Received | 2018-01-11 |
| Date of Report | 2017-12-07 |
| Date Mfgr Received | 2017-12-07 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2018-01-11 |
| 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 | 2018-01-11 |
| Model Number | TG118007ST |
| Catalog Number | TG118007ST |
| Lot Number | 14E01 |
| 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 | 2018-01-11 |