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MAYFIELD® A2600MRecalls & reported problems

Integra Lifesciences Corporation · MAYFIELD® SPINE TABLE ADAPTOR · Class 1

Adverse event reports
4
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780268062), received between Jun 16, 2021 and Mar 13, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem2
  • Device Dislodged or Dislocated1
  • Device Slipped1
  • Mechanics Altered1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Insufficient Information1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 13, 2024Device Slipped; Device Slipped

    THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2024-00033: A FACILITY REPORTED THAT DURING AN UNSPECIFIED CASE, THE MAYFIELD SPINE TABLE ADAPTOR METAL (A2600M) SLIPPED, RESULTING IN INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 18894988 ↗
  • MalfunctionDec 22, 2021Mechanics Altered; Mechanics Altered

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2021-00706: A FACILITY REPORTED THAT WHEN PATIENT WAS PUT IN PINS WITH MAYFIELD SKULL CLAMP AND THE MAYFIELD SPINE TABLE ADAPTOR BASE UNIT (A2600M), THE PATIENT MOVED DURING THE PROCEDURE AS THE PATIENT¿S POSITIONING CHANGED. THE HANDLE¿S RELEASING LEVER IS VERY LOOSE, AND THOUGHT TO BE THE ISSUE. THE CUSTOMER SENT IN BOTH UNITS FOR FURTHER INSPECTION DUE TO THE INCIDENT. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13061992 ↗
  • MalfunctionJun 17, 2021Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

    A FACILITY REPORTED THAT THE SHOCK CUSHION ON THE MAYFIELD SPINE TABLE ADAPTOR (A2600M) WAS DISLODGED AND IT WOULD NOT LOCK SAFELY. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY WAS REPORTED OR SURGICAL DELAY HAS BEEN REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12022003 ↗
  • MalfunctionJun 16, 2021Mechanical Problem; Mechanical Problem

    A FACILITY REPORTED THAT THE GOLD HANDLE ON THE MAYFIELD SPINE TABLE ADAPTOR METAL (A2600M) WOULD NOT LOCK SECURELY. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12009243 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.