MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-08-27 for IMPACTOR-ONLAY INSERT 160405 manufactured by Mako Surgical Corp..
| Report Number | 3005985723-2019-00602 |
| MDR Report Key | 8934921 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-08-27 |
| Date of Report | 2019-11-12 |
| Date of Event | 2019-07-24 |
| Date Mfgr Received | 2019-10-22 |
| Device Manufacturer Date | 2011-09-30 |
| Date Added to Maude | 2019-08-27 |
| 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 | MR. JOANN LAVATELLI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | MAKO SURGICAL CORP. |
| Manufacturer Street | 2555 DAVIE ROAD |
| Manufacturer City | FORT LAUDERDALE FL 33317 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33317 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPACTOR-ONLAY INSERT |
| Generic Name | PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM |
| Product Code | NPJ |
| Date Received | 2019-08-27 |
| Catalog Number | 160405 |
| Lot Number | 12080111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAKO SURGICAL CORP. |
| Manufacturer Address | 2555 DAVIE ROAD FORT LAUDERDALE FL 33317 US 33317 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-27 |