MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-26 for LEVEL ONE CMF 50-174-03-91 manufactured by Karl Leibinger Medizintechnik Gmbh & Co. Kg.
[128403917]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[128403918]
It was reported that a screw broke during implantation. A portion remained in the patient.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9610905-2018-00312 |
MDR Report Key | 8103556 |
Date Received | 2018-11-26 |
Date of Report | 2018-10-30 |
Date of Event | 2018-10-30 |
Date Facility Aware | 2019-01-29 |
Report Date | 2018-10-30 |
Date Reported to Mfgr | 2018-10-30 |
Date Mfgr Received | 2019-01-29 |
Date Added to Maude | 2018-11-26 |
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 32245 |
Manufacturer Country | US |
Manufacturer Postal | 32245 |
Manufacturer Phone | 9046417746 |
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 | 0 |
Brand Name | LEVEL ONE CMF |
Generic Name | SCREW |
Product Code | NEI |
Date Received | 2018-11-26 |
Model Number | 50-174-03-91 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
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 | 2018-11-26 |