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 2019-12-19 for FRENCH ROD BENDER 277030000 manufactured by Depuy Spine Inc.
[177176205]
If the information is unknown, not available or does not apply, the section/field of the form is left blank. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[177176206]
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019 during a posterior spinal fusion treating a thoracolumbar burst fracture a screw broke inside the unit while the surgeon was bending a rod with the rod bender (277030000) as the knob was turned to the direction of? Small.? There were fragments left in the patient. The procedure was completed with a replacement without surgical delay. Concomitant device reported: unknown rod (part#: unknown, lot#: unknown, quantity: 1). This report is for one french rod bender. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-52734 |
| MDR Report Key | 9496501 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-19 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-11-28 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2014-12-05 |
| Date Added to Maude | 2019-12-19 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRENCH ROD BENDER |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2019-12-19 |
| Returned To Mfg | 2019-12-12 |
| Model Number | 277030000 |
| Catalog Number | 277030000 |
| Lot Number | ER142571 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE INC |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-19 |