LEIBINGER Adverse Event — Malfunction (MDR MW5005570)
LEIBINGER Adverse Event — Malfunction (MDR MW5005570) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LEIBINGER; Generic name: 2.0MM SELF-TAPPING SCREW; Manufacturer: LEIBINGER.
| Device | LEIBINGER |
|---|---|
| Generic name | 2.0MM SELF-TAPPING SCREW |
| Manufacturer | LEIBINGER |
| Report number | MW5005570 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-01-18 |
| Narrative | PREOPERATIVE DIAGNOSIS OF MANDIBULAR HYPOPLASIA. ADMITTED IN 2008 TO THE SAME DAY SURGERY CENTER AND UNDERWENT A BILATERAL SAGITTAL SPLIT OSTEOTOMY WITH MIDLINE OSTEOTOMY. INTRAOPERATIVELY THE 2.0MM SELF-TAPPING SCREW FRACTURED UNDERNEATH THE HEAD. -TORSIONAL FAILURE- THE THREADED BOTTOM OF THE SCREW REMAINS IN THE PATIENT MINUS THE SCREW HEAD. NO PATIENT HARM AS PER THE SURGEON. |
| Source | openFDA MAUDE (device adverse events) |
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