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 2018-06-14 for KYPHON BONE FILLER DEVICE F04B manufactured by Medtronic Sofamor Danek Usa, Inc.
[110999101]
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. The following products were used in the surgery: product id , lot number , quantities (b)(4). Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[110999102]
It was reported that the patient underwent fusion at l5-s1 due to decompression. Intra-op, the first cement batch was prepared according to the "st" guide. It was administered to the bone filler devices in time but was impossible to fill. The surgeon felt that the lumen was too thin. The cement was already burnt. Had to throw four bone filler devices and start all over with a new cement and cds gun instead. Went better but when the four screws were filled the fns drivers couldn? T be removed. Two screws were pulled back as they didn? T have any good purchase anyway and changed to larger solid screws (7. 5x45). The other two was left in place as they had very good purchase in the bone. The driver was cut in half and the internal parts that had some kind of hard pressure on the screw tulips could finally be released and removed. The procedure took about 1. 5-2 hours longer time than expected due to this event. No patient complications were reported due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-00845 |
| MDR Report Key | 7599978 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-14 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-05-15 |
| Date Mfgr Received | 2018-05-15 |
| Device Manufacturer Date | 2008-08-11 |
| Date Added to Maude | 2018-06-14 |
| 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 | 3 |
| Brand Name | KYPHON BONE FILLER DEVICE |
| Generic Name | DISPENSER, CEMENT |
| Product Code | KIH |
| Date Received | 2018-06-14 |
| Model Number | NA |
| Catalog Number | F04B |
| Lot Number | UNK |
| Device Expiration Date | 2009-11-30 |
| 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 | 2018-06-14 |