MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-24 for NEUFLEX PIP IMPLANT SZ 1 123310000 manufactured by Depuy Orthopaedics Inc Us.
[124838951]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[124838952]
On (b)(6) a neuflex joint revision was done due to a broken neuflex implant. The old neuflex was removed and the same size was put in. I do not have access to the broken implant. I do not have patient information and i do not know when the original surgery took place. The reason for the delay of report is that i typically do not do joint cases and wasn't familiar with the complaint process. Patient consequence? No. Is the information being submitted for this complaint all the details that are known/available regarding this event? Yes.
Patient Sequence No: 1, Text Type: D, B5
[128409091]
(b)(4). Investigation summary: no device associated with this report was received for examination. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2018-73389 |
| MDR Report Key | 8000046 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-10-03 |
| Date Mfgr Received | 2018-11-26 |
| Date Added to Maude | 2018-10-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 19380XXXX |
| Manufacturer Country | US |
| Manufacturer Postal | 19380XXXX |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUFLEX PIP IMPLANT SZ 1 |
| Generic Name | NEUFLEX IMPLANT : FINGER IMPLANT |
| Product Code | KYJ |
| Date Received | 2018-10-24 |
| Catalog Number | 123310000 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-24 |