NA 394.35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982199676), received between Mar 23, 2021 and Mar 23, 2021 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHEN M., ET AL (2021) LATERAL DISTRACTOR USE DURING INTERNAL FIXATION OF TIBIAL PLATEAU FRACTURES HAS A MINIMAL RISK OF IATROGENIC PERONEAL NERVE PALSY, JOURNAL OF ORTHOP TRAUMA, VOLUME 35:PAGES E51¿E55 (USA). THIS STUDY AIMS TO DETERMINE THE APPLICATION OF AN INTRAOPERATIVE LATERAL DISTRACTOR FOR VISUALIZATION AND REDUCTION OF THE LATERAL TIBIAL PLATEAU IS SAFE AND POSES A MINIMAL RISK FOR IATROGENIC PERONEAL NERVE INJURY. OVER THE LAST 10 YEARS, ALL PATIENTS WHO HAD TIBIAL PLATEAU FRACTURES (TPFS) AND UNDERWENT ORIF WERE IDENTIFIED. A TOTAL OF 147 PATIENTS (81 FEMALES, 66 MALES) WITH MEAN AGE OF 52 YEARS THAT RECEIVED INTRAOPERATIVE APPLICATION OF A LATERAL DISTRACTOR WERE INCLUDED IN THE STUDY. FIXATION WAS DONE USING A 5.0-MM SELF-TAPPING SCHANZ PINS (SYNTHES, (B)(4)) AND LARGE UNIVERSAL DISTRACTOR (SYNTHES) WERE USED. STAGED EXTERNAL FIXATION WAS PERFORMED IN 23 PATIENTS, AND THE REST WERE TREATED WITH IMMEDIATE ORIF. THE STATUS OF THE PERONEAL NERVE WAS DETERMINED USING CLINICAL DOCUMENTATION FROM THE PREOPERATIVE SETTING, INPATIENT POSTOPERATIVE SETTING, AND THE FIRST 2-WEEK CLINIC FOLLOW-UP VISIT.

  Patient problems: Nerve Damage

  MAUDE report 11555191 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHEN M., ET AL (2021)LATERAL DISTRACTOR USE DURING INTERNAL FIXATION OF TIBIAL PLATEAU FRACTURES HAS A MINIMAL RISK OF IATROGENIC PERONEAL NERVE PALSY, JOURNAL OF ORTHOP TRAUMA, VOLUME 35:PAGES E51¿E55 (USA). THIS STUDY AIMS TO DETERMINE THE APPLICATION OF AN INTRAOPERATIVE LATERAL DISTRACTOR FOR VISUALIZATION AND REDUCTION OF THE LATERAL TIBIAL PLATEAU IS SAFE AND POSES A MINIMAL RISK FOR IATROGENIC PERONEAL NERVE INJURY. OVER THE LAST 10 YEARS, ALL PATIENTS WHO HAD TIBIAL PLATEAU FRACTURES (TPFS) AND UNDERWENT ORIF WERE IDENTIFIED.A TOTAL OF 147 PATIENTS (81 FEMALES,66 MALES) WITH MEAN AGE OF 52 YEARS THAT RECEIVED INTRAOPERATIVE APPLICATION OF A LATERAL DISTRACTOR WERE INCLUDED IN THE STUDY. FIXATION WAS DONE USING A 5.0-MM SELF-TAPPING SCHANZ PINS (SYNTHES, PAOLI, PA) AND LARGE UNIVERSAL DISTRACTOR (SYNTHES) WERE USED. STAGED EXTERNAL FIXATION WAS PERFORMED IN 23 PATIENTS, AND THE REST WERE TREATED WITH IMMEDIATE ORIF. THE STATUS OF THE PERONEAL NERVE WAS DETERMINED USING CLINICAL DOCUMENTATION FROM THE PREOPERATIVE SETTING, INPATIENT POSTOPERATIVE SETTING, AND THE FIRST 2-WEEK CLINIC FOLLOW-UP VISIT.

  Patient problems: Nerve Damage

  MAUDE report 11555112 ↗