MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-02-07 for KYPHON BONE CEMENT UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[178336833]
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
[178336854]
It was reported that the patient presented with deformity disease; and underwent open procedure at t11-t12, t12-l1, l1-l2, l3-l4, l4-l5 and l5-s1. Intra-op, cement hardened too fast and was no longer applicable. Then, another cement ('vertecam' from depuy) was opened and used. Only l5 screws were cemented with the alleged cement while the other screws were cemented with vertecam. Patient complications as a result of this event were unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2020-00155 |
| MDR Report Key | 9683385 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-07 |
| 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 | 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 | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHON BONE CEMENT |
| Product Code | NDN |
| Date Received | 2020-02-07 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |