MAYFIELD® A1083Recalls & reported problems
Integra Lifesciences Corporation · MAYFIELD® Disposable Adult Skull Pin (Stainless Steel) · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780025788), received between Dec 5, 2022 and Nov 9, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
- Sharp Edges1
- Unclear Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Skull Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2023Sharp Edges; Sharp Edges
A FACILITY REPORTED THAT WHEN THE MAYFIELD DISPOSABLE ADULT SKULL PINS (A1083) WAS ATTACHED TO THE PATIENT, THE BONE WAS BROKEN THROUGH (TABULA INTERNA); THE THORN/PIN WAS TOO SHARP. ADDITIONAL INFORMATION RECEIVED INDICATES THAT DURING POSITIONING OF THE PATIENT AND FIXATION OF THE SKULL CLAMP, THE PIN BROKE THROUGH THE SKULL/FRACTURE. PATIENT IS CURRENTLY REPORTED AS "OK", BUT HAS THE FRACTURE. THERE WAS DELAY OF 20 MINUTES REPORTED. FURTHER ADDITIONAL INFORMATION WAS RECEIVED STATING THAT "INDICATION OF SURGERY WAS OP: CAVERNOM AT PINEALIS-REGION."
Patient problems: Skull Fracture
MAUDE report 18107640 ↗MalfunctionDec 5, 2022Manufacturing, Packaging or Shipping Problem; Unclear Information; Manufacturing, Packaging or Shipping Problem; Unclear Information
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2022-00254: A FACILITY REPORTED THAT ONE OF THE SURGEONS WAS ABOUT TO USE PEDIATRIC PINS ON AN ADULT PATIENT, BUT FORTUNATELY REALIZED PRIOR TO THE CASE AND THE PINS WERE CHANGED. NURSE MANAGER BELIEVES THAT THE MAIN REASON WAS THAT THE PACKAGING FOR A1083 MAYFIELD ADULT PINS AND A1084 MAYFIELD PEDIATRIC PINS LOOKS SIMILAR IN SIZE AND THE PIN PROTECTORS ARE BOTH BLUE. THERE WAS NO PATIENT CONTACT AND NO DELAY IN SURGERY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15920656 ↗
Other HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) devices
- MAYFIELD® A1059Integra Lifesciences Corporation · HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)506 reports
- MAYFIELD® A3059Integra Lifesciences Corporation · HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)196 reports
- DORO® Skull Clamp 1001.001Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)173 reports
- Head Fixation Device HFD100IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall13 reports
- HFD100 119629-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall6 reports
- DORO® Skull Clamp 3003-009Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)52 reports
- HFD100 119695-000IMRIS Imaging, Inc. · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
- DORO® Easy-Connect Navigation Adaptor 1204.002Black Forest Medical GmbH · Holder, Head, Neurosurgical (Skull Clamp)1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.