NA 420.71Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587049342), received between Jan 8, 2018 and Jan 8, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJan 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: TSE, D: ET AL (2010) THE USE OF TITANIUM T-PLATE AS PLATFORM FOR GLOBE ALIGNMENT IN SEVERE PARALYTIC AND RESTRICTIVE STRABISMUS. AM J OPHTHALMOL, 150:404-411. (USA) THIS IS A RETROSPECTIVE STUDY TO EVALUATE LONG-TERM EFFECTIVENESS OF IMPROVED OCULAR ALIGNMENT USING A SUTURE/T-PLATE ANCHORING PLATFORM SYSTEM. THE SUTURE/T-PLATE FIXATION (SYNTHES CRANIOFACIAL 1.0-MM MODULE; SYNTHES CMF, (B)(4)) WAS USED TO CORRECT COMPLEX STRABISMUS FROM JANUARY 2003 TO DECEMBER 2007. THERE WERE 6 WOMEN AND 1 MAN WITH AN AVERAGE AGE OF 55.7 YEARS (RANGE, 24¿79 YEARS). THE TIP OF THE T-PLATE EXTENDS TO THE MEDIAL MID-ORBIT SUCH THAT THE SHAFT IS SITUATED BELOW THE FRONTOETHMOIDAL SUTURE LINE, AWAY FROM THE ANTERIOR AND POSTERIOR ETHMOIDAL ARTERIES. FOR SUTURE PLACEMENT, A FORNIX-BASED MEDIAL CONJUNCTIVAL PERITOMY IS MADE TO DELINEATE THE MEDIAL RECTUS INSERTION. SIX PATIENTS UNDERWENT BETWEEN 1 AND 3 STRABISMUS SURGERIES AND 4 PATIENTS RECEIVED BOTULINUM TOXIN TYPE A INJECTIONS TO THE ANTAGONIST MUSCLE PRIOR TO SUTURE T-PLATE PLACEMENT. ONLY 1 PATIENT DID NOT HAVE PREVIOUS STRABISMUS SURGERY OR BOTULINUM TOXIN INJECTIONS. ALL

  Patient problems: Eye Injury

  MAUDE report 7172108 ↗
• InjuryJan 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: TSE, D: ET AL (2010) THE USE OF TITANIUM T-PLATE AS PLATFORM FOR GLOBE ALIGNMENT IN SEVERE PARALYTIC AND RESTRICTIVE STRABISMUS. AM J OPHTHALMOL, 150:404-411. (USA) THIS IS A RETROSPECTIVE STUDY TO EVALUATE LONG-TERM EFFECTIVENESS OF IMPROVED OCULAR ALIGNMENT USING A SUTURE/T-PLATE ANCHORING PLATFORM SYSTEM. THE SUTURE/T-PLATE FIXATION (SYNTHES CRANIOFACIAL 1.0-MM MODULE; SYNTHES CMF, (B)(4)) WAS USED TO CORRECT COMPLEX STRABISMUS FROM JANUARY 2003 TO DECEMBER 2007. THERE WERE 6 WOMEN AND 1 MAN WITH AN AVERAGE AGE OF 55.7 YEARS (RANGE, 24¿79 YEARS). THE TIP OF THE T-PLATE EXTENDS TO THE MEDIAL MID-ORBIT SUCH THAT THE SHAFT IS SITUATED BELOW THE FRONTOETHMOIDAL SUTURE LINE, AWAY FROM THE ANTERIOR AND POSTERIOR ETHMOIDAL ARTERIES. FOR SUTURE PLACEMENT, A FORNIX-BASED MEDIAL CONJUNCTIVAL PERITOMY IS MADE TO DELINEATE THE MEDIAL RECTUS INSERTION. SIX PATIENTS UNDERWENT BETWEEN 1 AND 3 STRABISMUS SURGERIES AND 4 PATIENTS RECEIVED BOTULINUM TOXIN TYPE A INJECTIONS TO THE ANTAGONIST MUSCLE PRIOR TO SUTURE T-PLATE PLACEMENT. ONLY 1 PATIENT DID NOT HAVE PREVIOUS STRABISMUS SURGERY OR BOTULINUM TOXIN INJECTIONS. ALL

  Patient problems: Eye Injury

  MAUDE report 7172107 ↗