FDA Adverse Event
Injury
Summary report: N
DISTRACTION, INTERNAL
MDR report key: 6082899
·
Received November 7, 2016
Report
- Report Number
- 9610905-2016-00040
- Event Type
- Injury
- Date Received
- November 7, 2016
- Date of Event
- October 6, 2016
- Report Date
- October 17, 2016
- Manufacturer
- KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
- Product Code
- MQN
- UDI-DI
- 00888118083647
- PMA / PMN Number
- K010139
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION WAS PERFORMED ON THE BASIS OF COMPLAINT STATISTICS AS NO DEVICE WAS SENT BACK FOR EVALUATION. IT IS DETERMINED THAT THE COMPLAINT PERCENTAGE FALLS WELL WITHIN THE PRODUCT RISK LIMITS THAT ARE ADHERED TO AT KLM. THE PRODUCT HISTORY DEVICE RECORDS WERE ALSO REVIEWED BASED ON THE LOT NUMBER PROVIDED AND REVEALED NO ABNORMALITIES. DUE TO NO DEVICE BEING RETURNED, THE ROOT CAUSE FOR THE FAILURE CANNOT BE DETERMINED. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
CONE SHAFT ON THE DISTAL END OF THE DISTRACTOR BROKE OFF. DISTRACTOR WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 735030 | DISTRACTION, INTERNAL | DISTRACTOR | MQN | KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG | 51-643-50-09 | 33169563 | 00888118083647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 YR | Other |