MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-01-11 for SLF TAPPING ROOF PILE SCRW35MM 101140035 manufactured by Depuy Orthopaedics Inc Us.
[132796430]
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4). Reporter is an attorney.
Patient Sequence No: 1, Text Type: N, H10
[132796431]
Pfs alleges infection, dislocation, muscle damage and anemia. After the review of medical records for mdr reportability,patient was revised to address dislocation,status post complex right revision. Revision notes reported of anterior dislocation. Clinical notes reported of staph infection and purulent drainage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-80586 |
| MDR Report Key | 8239798 |
| Report Source | OTHER |
| Date Received | 2019-01-11 |
| Date of Report | 2018-12-17 |
| Date of Event | 2010-06-24 |
| Date Mfgr Received | 2019-07-26 |
| Device Manufacturer Date | 2009-09-29 |
| Date Added to Maude | 2019-01-11 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| 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 | SLF TAPPING ROOF PILE SCRW35MM |
| Generic Name | BONE SCREWS AND PINS : SCREWS |
| Product Code | JDJ |
| Date Received | 2019-01-11 |
| Catalog Number | 101140035 |
| Lot Number | D4FAA1000 |
| Device Expiration Date | 2019-09-30 |
| 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 | 1. Required No Informationntervention | 2019-01-11 |