MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-28 for TIBIAL INSERT IMPACTOR TIP ED-03475 manufactured by Conformis, Inc..
[74080794]
Lot numbers: l142001, f160301, g131601, k150101, j160101, c160101.
Patient Sequence No: 1, Text Type: N, H10
[74080795]
Periodic review of items removed from reusable instrument trays during reprocessing was completed. Review showed that six tibial insert impactor tips were broken.
Patient Sequence No: 1, Text Type: D, B5
[86895932]
Lot numbers: l142001, f160301, g131601, k150101, j160101, c160101. Periodic review of items removed from reusable instrument trays during reprocessing was completed. Review showed that six tibial insert impactor tips were broken. Review of the lot history records indicate that the devices were manufactured to specification. A cause of failure can not be conclusively determined from the available information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004153240-2017-00087 |
| MDR Report Key | 6529122 |
| Date Received | 2017-04-28 |
| Date of Report | 2017-06-21 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-03-17 |
| Date Added to Maude | 2017-04-28 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIBIAL INSERT IMPACTOR TIP |
| Generic Name | REUSABLE IMPACTOR COMPONENT |
| Product Code | OOG |
| Date Received | 2017-04-28 |
| Catalog Number | ED-03475 |
| Lot Number | *SEE MFG NARRATIVE |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-04-28 |