MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-31 for LAG SCREWDRIVER GAMMA3? 380X110MM 1320-0200 13200200 manufactured by Stryker Trauma Kiel.
| Report Number | 0009610622-2020-00136 |
| MDR Report Key | 9907794 |
| Report Source | FOREIGN |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-31 |
| 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. KEVIN SMITH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER TRAUMA KIEL |
| Manufacturer Street | PROF. KUENTSCHER-STRASSE 1-5 |
| Manufacturer City | SCHOENKIRCHEN/KIEL D-24232 |
| Manufacturer Country | DE |
| Manufacturer Postal Code | D-24232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAG SCREWDRIVER GAMMA3? 380X110MM |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | LXH |
| Date Received | 2020-03-31 |
| Model Number | 1320-0200 |
| Catalog Number | 13200200 |
| Lot Number | K43452 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER TRAUMA KIEL |
| Manufacturer Address | PROF. KUENTSCHER-STRASSE 1-5 SCHOENKIRCHEN/KIEL D-24232 DE D-24232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |