MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-28 for 13G 5IN MATCH-GROUND FOUR FACET TIP INTRODUCTION NEEDLE 0306130000 manufactured by Stryker Instruments-kalamazoo.
[128630930]
Device discarded.
Patient Sequence No: 1, Text Type: N, H10
[128630931]
It was reported that during a vertebroplasty procedure, that the patient's blood pressure dropped due to the physician cutting a nerve. Medical intervention was necessary for a small chest bleed by inserting a coil to prevent further bleeding. The patient was admitted to the icu. Upon follow up, the initial reporter was not able to provide any further information regarding the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2018-02562 |
| MDR Report Key | 8111656 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-10-30 |
| Date Added to Maude | 2018-11-28 |
| 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. ZACH BAKER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 13G 5IN MATCH-GROUND FOUR FACET TIP INTRODUCTION NEEDLE |
| Generic Name | INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT) |
| Product Code | OAR |
| Date Received | 2018-11-28 |
| Catalog Number | 0306130000 |
| Lot Number | KQK0 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-28 |