DISTRACTION
Received Feb 14, 2023
Report 9610905-2023-00001 · MDR key 16375234
Device
Generic name
Distractor
Manufacturer
Karl Leibinger Medizintechnik Gmbh & Co. KgModel number
51-563-30-71Lot number
33507282
Product problems
- Failure to Advance
- Adverse Event Without Identified Device or Use Problem
- Failure to Advance
- Adverse Event Without Identified Device or Use Problem
Patient
6 MO · Female
- Impaired Healing
- Impaired Healing
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A DISTRACTOR WOULD NOT ADVANCE. IT WAS REMOVED AND REPLACED.
Additional Manufacturer Narrative
AN INVESTIGATION WAS PERFORMED IN THE LAB AND 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 IS PATIENT RELATED AS NO DEVICE ISSUE WAS FOUND. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.