MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-14 for ITOTAL CR TIBIAL TRAY IMPACTOR TIP ED-04258 manufactured by Conformis, Inc..
[133185950]
It was reported that the tibial insert impactor broke off inside the impactor handle, rendering the handle as unusable. The case was completed successfully. Review of the device history record indicates that the device was manufactured to specification.
Patient Sequence No: 1, Text Type: N, H10
[133185951]
It was reported that the tibial insert impactor broke off inside the impactor handle, rendering the handle as unusable. The case was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004153240-2019-00029 |
| MDR Report Key | 8245759 |
| Date Received | 2019-01-14 |
| Date of Report | 2019-01-14 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2018-12-15 |
| Date Added to Maude | 2019-01-14 |
| 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 | THOMAS HAUETER |
| Manufacturer Street | 600 TECHNOLOGY PARK DRIVE |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal | 01821 |
| Manufacturer Phone | 7813459161 |
| Manufacturer G1 | CONFORMIS, INC. |
| Manufacturer Street | 600 RESEARCH DRIVE |
| Manufacturer City | WILMINGTON MA 01887 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01887 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ITOTAL CR TIBIAL TRAY IMPACTOR TIP |
| Generic Name | REUSABLE IMPLACTOR COMPONENT |
| Product Code | OOG |
| Date Received | 2019-01-14 |
| Catalog Number | ED-04258 |
| Lot Number | D142401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONFORMIS, INC. |
| Manufacturer Address | 600 TECHNOLOGY PARK DRIVE BILLERICA MA 01821 US 01821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-14 |