MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for SCREWDRIVER 26-975-39-07 manufactured by Karl Leibinger Medizintechnik Gmbh & Co. Kg.
[186135274]
(b)(4). Reference exemption number e2017029.
Patient Sequence No: 1, Text Type: N, H10
[186135275]
It was reported that a screwdriver broke and a portion remained implanted.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9610905-2020-00032 |
MDR Report Key | 9885083 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-03-26 |
Date of Report | 2020-02-26 |
Date of Event | 2020-02-24 |
Date Facility Aware | 2020-02-26 |
Report Date | 2020-02-26 |
Date Reported to Mfgr | 2020-02-26 |
Date Mfgr Received | 2020-02-26 |
Date Added to Maude | 2020-03-26 |
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 | MS. JENNIFER DAMATO |
Manufacturer Street | P.O. BOX 16369 |
Manufacturer City | JACKSONVILLE, FL |
Manufacturer Country | US |
Manufacturer Phone | 6417746 |
Manufacturer G1 | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
Manufacturer Street | KOLBINGER STRASSE 10 |
Manufacturer City | MUEHLHEIM/DONAU, 78570 |
Manufacturer Country | GM |
Manufacturer Postal Code | 78570 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SCREWDRIVER |
Generic Name | SCREWDRIVER |
Product Code | HXX |
Date Received | 2020-03-26 |
Model Number | 26-975-39-07 |
Lot Number | KDA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
Manufacturer Address | KOLBINGER STRASSE 10 MUEHLHEIM/DONAU, 78570 GM 78570 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-03-26 |