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 2019-11-27 for DISTRACTION 51-557-20-09 manufactured by Karl Leibinger Medizintechnik Gmbh & Co. Kg.
[168575151]
Kls-martin l. P. (importer) is submitting this report on behalf of karl leibinger medizintechnik gmbh & co. Kg (manufacturer). Reference exemption number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[168575152]
It was reported the distractor broke. It was removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
[184390286]
An investigation was performed using a stereo microscope revealed tensile cracks. Further observation determined there were no indications of material or manufacturing defects. The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm. During the investigation the product lot number identified was reviewed in the device history records. The dhr review showed no discrepancies or anomalies. The investigation results conclude that the root cause for breakages were due to structural failure of the device due to mechanical overload. 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
| Report Number | 9610905-2019-00222 |
| MDR Report Key | 9386728 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-27 |
| Date of Report | 2019-10-28 |
| Date of Event | 2019-10-28 |
| Date Facility Aware | 2019-10-28 |
| Report Date | 2019-10-28 |
| Date Reported to Mfgr | 2019-10-28 |
| Date Mfgr Received | 2019-10-28 |
| Date Added to Maude | 2019-11-27 |
| 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 | DISTRACTION |
| Generic Name | DISTRACTION |
| Product Code | MQN |
| Date Received | 2019-11-27 |
| Model Number | 51-557-20-09 |
| Lot Number | 33319562 |
| 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 | 2019-11-27 |