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 2019-03-18 for LEVEL ONE CMF 25-092-12-91 manufactured by Karl Leibinger Medizintechnik Gmbh & Co. Kg.
[139070645]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139070646]
It was reported that a screw broke during implantation. A portion remains implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610905-2019-00083 |
| MDR Report Key | 8428571 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-18 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-03-04 |
| Date Facility Aware | 2019-05-20 |
| Report Date | 2019-03-04 |
| Date Reported to Mfgr | 2019-03-04 |
| Date Mfgr Received | 2019-05-20 |
| Date Added to Maude | 2019-03-18 |
| 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 | 3 |
| Brand Name | LEVEL ONE CMF |
| Generic Name | SCREW |
| Product Code | DZL |
| Date Received | 2019-03-18 |
| Model Number | 25-092-12-91 |
| 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 | 2019-03-18 |