MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-13 for TIBIAL INSERT IMPACTOR TIP ED-03475 manufactured by Conformis, Inc..
[87220910]
It was reported that the tibial insert impactor tip broke during surgery. The surgery was competed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004153240-2017-00194 |
| MDR Report Key | 6860989 |
| Date Received | 2017-09-13 |
| Date of Report | 2017-09-13 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-08-15 |
| Date Added to Maude | 2017-09-13 |
| 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 | KARINA SNOW |
| Manufacturer Street | 600 TECHNOLOGY PARK DRIVE |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal | 01821 |
| Manufacturer Phone | 7813459195 |
| Manufacturer G1 | CONFORMIS, INC. |
| Manufacturer Street | 600 RESEARCH DR. |
| 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 | TIBIAL INSERT IMPACTOR TIP |
| Generic Name | REUSABLE IMPACTOR COMPONENT |
| Product Code | OOG |
| Date Received | 2017-09-13 |
| Catalog Number | ED-03475 |
| Lot Number | A172501 |
| Operator | PHYSICIAN |
| 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 | 2017-09-13 |