MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-03 for UNKNOWN_K2M_PRODUCT UNK_SPE manufactured by Stryker Spine-leesburg.
| Report Number | 3004774118-2019-00113 |
| MDR Report Key | 9153157 |
| Date Received | 2019-10-03 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-05-21 |
| Date Added to Maude | 2019-10-03 |
| 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 | MR. MARGARITA KARAN |
| Manufacturer Street | 2 PEARL COURT |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017608000 |
| Manufacturer G1 | STRYKER SPINE-LEESBURG |
| Manufacturer Street | 600 HOPE PARKWAY SE |
| Manufacturer City | LEESBURG VA 20175 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 20175 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNKNOWN_K2M_PRODUCT |
| Generic Name | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
| Product Code | MQP |
| Date Received | 2019-10-03 |
| Catalog Number | UNK_SPE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SPINE-LEESBURG |
| Manufacturer Address | 600 HOPE PARKWAY SE LEESBURG VA 20175 US 20175 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-03 |