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Spencer Probe Depth Electrode SD08R-SP05X-000 (UDI 00841823109286)Recalls & reported problems

Ad-Tech Medical Instrument Corporation · Class 2

All models of Spencer Probe Depth Electrode (16)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841823109286), received between Jun 24, 2026 and Jun 24, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 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: 1 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

  • Fracture1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 24, 2026Fracture

    ON (B)(6) 2026, DURING A PROCEDURE AT A HEALTHCARE FACILITY, ONE DEPTH ELECTRODE CEASED RECORDING. TROUBLESHOOTING WAS PERFORMED, AND IT WAS DETERMINED THAT THE ELECTRODE REQUIRED REPLACEMENT. DURING ATTEMPTED REMOVAL, SIGNIFICANT RESISTANCE WAS ENCOUNTERED AND THE ELECTRODE COULD NOT BE WITHDRAWN. AN ADJACENT ELECTRODE WAS REMOVED TO RULE OUT POTENTIAL INTERFERENCE; HOWEVER, RESISTANCE PERSISTED. DURING CONTINUED REMOVAL ATTEMPTS, THE ELECTRODE FRACTURED, LEAVING THE DISTAL PORTION WITH ALL EIGHT CONTACTS RETAINED WITHIN THE PATIENT. A SURGICAL BURR HOLE WAS CREATED TO FACILITATE ACCESS AND REMOVAL OF THE RETAINED COMPONENTS. THE FRAGMENTED ELECTRODE SECTION AND AN ASSOCIATED PORTION OF THE ANCHOR BOLT TIP WERE SUCCESSFULLY RETRIEVED. POST-EVENT ASSESSMENT SUGGESTED THAT THE ANCHOR BOLT MAY HAVE BEEN DAMAGED DURING DRILLING, RESULTING IN STRUCTURAL COMPROMISE THAT CONTRIBUTED TO ELECTRODE DAMAGE AND FRACTURE DURING REMOVAL.

    Patient problems: Foreign Body In Patient

    MAUDE report 25607974 ↗

Other ELECTRODE, DEPTH devices

All ELECTRODE, DEPTH devices →

Sources and updates

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