NA 04.615.601Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034740843), received between Jun 30, 2022 and Jun 12, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2024Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  IT WAS REPORTED AN OCCIPITO-CERVICAL FUSION (OCCIPITAL BONE-T2) WAS PERFORMED ON (B)(6) 2023. AFTER THE SURGERY, ON (B)(6) 2024, THE SALES REP WAS INFORMED THE INFECTION OF THE UPPER THORACIC TO CERVICAL TRANSITION REGION. THE SECOND SURGERY WAS PERFORMED ON (B)(6) 2024. IN THE REVISION SURGERY, THE BREAKAGE OF THE PLATE IN QUESTION WAS CONFIRMED. REMOVAL OF THE PLATE WAS CONSIDERED, BUT WAS NOT REMOVED BY THE SURGEON'S DECISION BECAUSE IT WAS NOT PART OF THE ORIGINAL SURGICAL PLANNING. THERE WAS NO INSTRUMENTATION FOR REMOVAL OF THE PLATE, AND THERE WAS A RISK OF INSTABILITY FROM REMOVAL OF THE OCCIPITAL PLATE. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE TI OCCIPITAL PLATE-MEDIAL 50MM WIDTH FOR 4.0MM RODS THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Unspecified Infection

  MAUDE report 19522246 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION (O-C4) ON (B)(6) 2023 THAT WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2023 THE PATIENT CAME TO THE OUTPATIENT CLINIC, WHERE IT WAS DISCOVERED THAT THE TWO SCREWS IN QUESTION HAD LOOSENED FROM THE OCCIPITAL BONE. REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2023 TO REPLACE THE OCCIPITAL BONE PLATE AND THE BONE SCREWS IN QUESTION. THE CAUSE OF THE LOOSENING IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI OCCIPITAL PLATE-MEDIAL 50MM WIDTH FOR 4.0MM RODS. THIS IS REPORT 4 OF 4 FOR (B)(4)..

  Patient problems: Insufficient Information

  MAUDE report 18346009 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED ON JUNE 7, 2022, THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A PRIMARY POSTERIOR CERVICAL FUSION IN THE OCCIPITAL BONE FOR TREATING VESTIBULAR NEURONITIS. ON (B)(6) 2022 IT WAS REPORTED THAT THE ROD (UNK) MIGHT HAVE COME OFF. ON (B)(6) 2022 THE PATIENT UNDERWENT A REVISION PROCEDURE. SUBSEQUENT TO THE AFOREMENTIONED THE FOLLOWING REPORTS WERE MADE: 1. THE PATIENT HAS BECOME INFECTIOUS INCLUDING MRSA. IT TAKES FOR GRANTED THAT THE INFECTION WAS TRIGGERED BY THE PROTRUDED ROD THROUGH THE SCALP. 2. THE LESION WAS CLEANSED ON THE FIRST WEEK OF (B)(6) 2022. 3. SEVERITY OF THE INFECTION WAS EVALUATED AS "MILD." ANY FURTHER SYMPTOM OF THE INFECTION HAS NOT BEEN RECOGNIZED. HOWEVER, THE PATIENT HAS BEEN HOSPITALIZED, AND THE WOUND ON THE SCALP NEEDS DAILY TREATMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) OCCIPITAL-PL 4.5/5 MED W/50 F/R Ø4 TI. THIS IS REPORT 2 OF 2 FOR COMPLAINT PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14880484 ↗