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 2020-02-19 for DISTRACTION 50-347-07-09 manufactured by Karl Leibinger Medizintechnik Gmbh & Co. Kg.
[184296306]
(b)(4). Reference exemption number e2017029. An investigation was performed on the basis of complaint statistics as no device was returned for evaluation. The failure root cause cannot be determined due to the device not being returned. Based on the information provided the most likely root cause is patient condition due to possible early healing of the osteotomy. If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184296307]
It was reported that the screws pulled out during activation of the distractor possible due to early healing of the osteotomy. The screws were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610905-2020-00009 |
| MDR Report Key | 9726392 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-07 |
| Date Facility Aware | 2020-02-07 |
| Report Date | 2020-02-07 |
| Date Reported to Mfgr | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-19 |
| 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 | DISTRACTION |
| Generic Name | DISTRACTION |
| Product Code | MQN |
| Date Received | 2020-02-19 |
| Model Number | 50-347-07-09 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-19 |