MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for STRYKER MANDIBULAR DISTRACTOR 2 manufactured by Stryker Leibinger Gmbh & Co. Kg.
[180888337]
Reporter reports internal distractor broke through son's skin. The surgeon went back to pull it back up. Approx (b)(6) 2019, distractor broke through son's skin again. The removal of the device took place (b)(6) 2019. The surgeon discovered the foot plate of both sides of the jaw broke off of both distractor. It was a failed distractor that resulted in malalignment and impair function of the jaw. Pt is now on a soft liquid diet and has impaired speech because of failed distractor. Reporter states the device is only fda approves for up to age four, so they used the device on her son without notification of off-label use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093193 |
| MDR Report Key | 9744476 |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2019-08-10 |
| Date Added to Maude | 2020-02-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER MANDIBULAR DISTRACTOR 2 |
| Generic Name | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR |
| Product Code | MQN |
| Date Received | 2020-02-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER LEIBINGER GMBH & CO. KG |
| Brand Name | STRYKER MANDIBULAR DISTRACTOR 2 |
| Generic Name | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR |
| Product Code | MQN |
| Date Received | 2020-02-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | STRYKER LEIBINGER GMBH & CO. KG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-21 |