MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-04-13 for PINN CAN BONE SCREW 6.5MMX35MM 121735500 manufactured by Depuy Orthopaedics Inc Us.
[72743760]
(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
[72743761]
The patient was revised to address an infection.
Patient Sequence No: 1, Text Type: D, B5
[109410662]
(b)(4). Investigation summary: no device associated with this report was received for examination. 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
[109410663]
The patient was revised to address an infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2017-16471 |
| MDR Report Key | 6490954 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-04-13 |
| Date of Report | 2017-04-10 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2018-02-27 |
| Device Manufacturer Date | 2016-09-19 |
| Date Added to Maude | 2017-04-13 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | JJMSZ PLANT FOR STK. & N-STK. |
| Manufacturer Street | NO. 299, CHANGYANG STREET SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU, JIANGSU 215126 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN CAN BONE SCREW 6.5MMX35MM |
| Generic Name | HIP OTHER IMPLANT |
| Product Code | NDJ |
| Date Received | 2017-04-13 |
| Catalog Number | 121735500 |
| Lot Number | D16010557 |
| 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 SUZHOU INDUSTRIAL PARK WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-13 |