MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-06-03 for KYPHON XPANDER INFLATABLE BONE TAMP K09A manufactured by Medtronic Mexico.
| Report Number | 9612164-2019-02134 |
| MDR Report Key | 8664678 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-06-03 |
| Date of Report | 2019-07-31 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2019-07-26 |
| Date Added to Maude | 2019-06-03 |
| 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 MEXICO |
| Manufacturer Street | AV. PASEO DEL CUCAPAH #10510 |
| Manufacturer City | TIJUANA,BC 22570 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KYPHON XPANDER INFLATABLE BONE TAMP |
| Generic Name | TAMP |
| Product Code | HXG |
| Date Received | 2019-06-03 |
| Returned To Mfg | 2019-07-26 |
| Model Number | NA |
| Catalog Number | K09A |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MEXICO |
| Manufacturer Address | AV. PASEO DEL CUCAPAH #10510 TIJUANA,BC 22570 MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-03 |