FDA Adverse Event
Injury
Summary report: N
MICRO ZURICH DISTRACTOR
MDR report key: 4600153
·
Received March 9, 2015
Report
- Report Number
- 9610905-2015-00010
- Event Type
- Injury
- Date Received
- March 9, 2015
- Date of Event
- February 11, 2015
- Report Date
- March 6, 2015
- Manufacturer
- KARL LEIBINGER MEDIZINTECHNIK GMBH. CO. KG
- Product Code
- MQN
- PMA / PMN Number
- K010139
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING IMPLANTATION OF THE DISTRACTOR, THE FOOT PLATE DETACHED FROM THE ACTIVATION ROD WHEN THE ANESTHESIOLOGIST WAS INSERTING AN AIRWAY TUBE. A CT SCAN CONFIRMED THE BROKEN FOOT PLATE. THE BROKEN DISTRACTOR HAD TO BE REMOVED IN A SECOND SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 160443 | MICRO ZURICH DISTRACTOR | DISTRACTOR | MQN | KARL LEIBINGER MEDIZINTECHNIK GMBH. CO. KG | 51-424-30-09 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 MO | Other |