MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-02 for IFORMA M57210600010 manufactured by Conformis, Inc..
[125917243]
Patient "repored" disc failure, immobility and pain. Revision surgery is planned to exchange the poly inserts. Review of the device history record indicates that device was manufactured to specification.
Patient Sequence No: 1, Text Type: N, H10
[125917244]
Patient "repored" disc failure, immobility and pain. Revision surgery is planned to exchange the poly inserts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004153240-2018-00243 |
| MDR Report Key | 8032293 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2009-09-30 |
| Date Added to Maude | 2018-11-02 |
| 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 TECHNOLOGY PARK DRIVE |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IFORMA |
| Generic Name | KNEE INTERPOSITIONAL DEVICE |
| Product Code | HSH |
| Date Received | 2018-11-02 |
| Catalog Number | M57210600010 |
| Device Expiration Date | 2018-09-28 |
| 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 | 1. Required No Informationntervention | 2018-11-02 |