MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-19 for INSTRUMENT, BENDING OR CONTOURING 5584260 manufactured by Medtronic Sofamor Danek Usa, Inc.
[100403930]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[100403971]
Pre-operative diagnosis: scoliosis levels operated: t4-l2 it was reported that intra-op, while performing rod bending, the bender broke. The broken bender stabbed patient's soft tissue causing bleeding (300 ml instantly), which was then stopped with sealant (surgiflo) and tachosil. It caused disturbance to the mep, but eventually closure of wound was successful. No fragment of the broken product remained inside the patient. No patient complications were reported after this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-00248 |
| MDR Report Key | 7279661 |
| Date Received | 2018-02-19 |
| Date of Report | 2018-02-19 |
| Date of Event | 2018-01-24 |
| Date Mfgr Received | 2018-01-24 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2018-02-19 |
| 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 | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INSTRUMENT, BENDING OR CONTOURING |
| Generic Name | INSTRUMENT, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2018-02-19 |
| Model Number | NA |
| Catalog Number | 5584260 |
| Lot Number | CT11L006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-19 |