MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-09-27 for STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM 03.100.018 manufactured by Wrights Lane Synthes Usa Products Llc.
| Report Number | 2939274-2019-61020 |
| MDR Report Key | 9131557 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-09-27 |
| Date of Report | 2019-09-04 |
| Date Mfgr Received | 2019-10-03 |
| Device Manufacturer Date | 2018-04-10 |
| Date Added to Maude | 2019-09-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM |
| Generic Name | RETRACTOR |
| Product Code | GAD |
| Date Received | 2019-09-27 |
| Returned To Mfg | 2019-10-03 |
| Catalog Number | 03.100.018 |
| Lot Number | T164536 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-27 |