MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-07-01 for CURVED PEDICLE PROBE 2.4MM 03.614.013 manufactured by Wrights Lane Synthes Usa Products Llc.
[149778897]
Device available: device returned. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. A review of the device history record has been requested. Device was used for treatment, not diagnosis. 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
[149778898]
It was reported that on an unknown date, during a routine incoming inspection, it was discovered that the curved pedicle probe was broken. There was no patient involvement. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-58950 |
| MDR Report Key | 8750243 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-07-01 |
| Date of Report | 2019-06-04 |
| Date Mfgr Received | 2019-08-06 |
| Device Manufacturer Date | 2018-04-16 |
| Date Added to Maude | 2019-07-01 |
| 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 | WERK H |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURVED PEDICLE PROBE 2.4MM |
| Generic Name | PROBE |
| Product Code | HXB |
| Date Received | 2019-07-01 |
| Returned To Mfg | 2019-06-17 |
| Model Number | 03.614.013 |
| Catalog Number | 03.614.013 |
| Lot Number | L776504 |
| 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 | 2019-07-01 |