MAYFIELD® A2114Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10381780253761), received between Mar 25, 2021 and May 8, 2026 — classified as 17 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (19 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Break

  A FACILITY REPORTED THAT AFTER PINNING THE PATIENT BUT STILL POSITIONING THE MAYFIELD INFINITY XR2 SKULL CLAMP (A2114), THE ROCKER ARM BROKE FROM THE LOCKED POSITION. THE PATIENT'S HEAD WAS STILL BEING HELD BUT THE MOVEMENT DID CAUSE A SMALL LACERATION ON THE PATIENTS HEAD. THE PHYSICIAN ATTEMPTED TO RELOCK THE ROCKER ARM AND THEN REPOSITION. HOWEVER, THE ROCKER ARM AGAIN "COULD NOT WITHSTAND THE TORQUE OF THE POSITION" AND BROKE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Laceration(s)

  MAUDE report 25126150 ↗
• InjuryNov 13, 2025Device Slipped; Device Slipped

  A FACILITY REPORTED THAT MAYFIELD INFINITY XR2 SKULL CLAMP (A2114) WAS USED IN A POSTERIOR CERVICAL FUSION PROCEDURE AND THE PIN SLIPPED CAUSING AN ABRASION TO THE PATIENT'S HEAD. THE LOCK DID NOT STAY ENGAGED FOR THE PROCEDURE. NO SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: Abrasion

  MAUDE report 23544288 ↗
• MalfunctionOct 9, 2025Unstable; Unstable

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23259901 ↗
• InjuryAug 22, 2025Vibration; Vibration

  THIS REPORT IS 1 OF 2 AND LINKED TO MFG REPORT NUMBER 3004608878-2025-00169: A FACILITY REPORTED THAT THE MAYFIELD INFINITY XR2 SKULL CLAMP (A2114) WAS USED IN A CRANIOTOMY PROCEDURE, AND WHILE THE PATIENT WAS DRAPED AND MICROSCOPE WAS IN USE, THE SURGEON FELT A VIBRATION. THEY CHECKED THE PATIENT, AND EVERYTHING APPEARED TO BE FINE. HOWEVER, THE PATIENT MOVED, AND THEY CHECKED AND SAW THAT THE BASE UNIT HAD MOVED AND THE PATIENT HEAD FELL OUT OF THE PINS CAUSING 2 LACERATIONS OF 1-2 INCHES TO THE BACK OF THE HEAD. TWO SEPARATE SURGICAL STAPLES STAPLES WERE REQUIRED. THERE WAS NO DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DISCHARGED WITH NO NOTABLE PHYSICAL INJURY OTHER THAN THE 2 LACERATIONS.

  Patient problems: Laceration(s)

  MAUDE report 22878751 ↗
• MalfunctionJun 20, 2025Mechanics Altered; Mechanics Altered

  A FACILITY REPORTED THAT THE PLUNGER OF THE MAYFIELD INFINITY XR2 SKULL CLAMP (A2114) WAS NOT ENGAGING OR LOCKING IN PLACE WHEN PATIENT WAS TURNED OVER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22296955 ↗
• InjuryJun 20, 2025Device Slipped; Device Slipped

  A FACILITY REPORTED THAT DURING POSITIONING FOR A CRANIOTOMY PROCEDURE, THE MAYFIELD INFINITY XR2 SKULL CLAMP (A2114) SLIPPED CAUSING A LACERATION TO THE HEAD REQUIRING SUTURES TO BE PLACED. THE SKULL CLAMP WAS REMOVED FROM SERVICE AND REPLACED WITH A DIFFERENT SKULL CLAMP.

  Patient problems: Laceration(s)

  MAUDE report 22296946 ↗
• MalfunctionMay 7, 2025Device Slipped; Device Slipped

  WORLD NEUROSURGERY (2020) PUBLISHED AN ARTICLE TITLED, "INTRAOPERATIVE HEAD SLIPPAGE WITH THE HEAD CLAMP SYSTEM CAN OCCUR DURING EPILEPTIC SURGERY." THIS IS 3 OF 3 REPORTS FOR PATIENT #3 SHOWN IN TABLE 2 OF THE LITERATURE AND LINKED TO MFG REPORT NUMBERS 3004608878-2025-00084 AND 3004608878-2025-00085: BACKGROUND - DURING NEUROSURGERY, WE USE A HEAD CLAMP SYSTEM FOR FIRM HEAD FIXATION. HOWEVER, WE HAVE ENCOUNTERED SLIPPAGE USING THE HEAD CLAMP SYSTEM, ALTHOUGH THIS HAS NOT BEEN ADEQUATELY STUDIED. IN THE PRESENT STUDY, TO INCREASE THE RELIABILITY OF THE ANALYSIS USING A MORE HOMOGENEOUS TYPE OF PATIENT DATA, WE CONDUCTED A PROSPECTIVE STUDY OF PATIENTS WHO HAD UNDERGONE EPILEPTIC SURGERY. WE EXAMINED THE POTENTIAL RISK FACTORS FOR HEAD SLIPPAGE AND POSTULATED THAT THE LOCATION OF THE PINS MIGHT BE IMPORTANT. PATIENTS - THE PARTICIPANTS WERE JAPANESE PATIENTS WHO HAD BEEN TREATED FROM JUNE 2019 TO FEBRUARY 2020 AT THE COMPREHENSIVE EPILEPSY CENTER, SEIREI HAMAMATSU GENERAL HOSPITAL. MALFUNCTION - HEAD SLIPPAGE HAD OCCURRED IN 3 OF THE 21 PATIENTS (14.3°/O; TABLE 2). THE DISTANCE BETWEEN THE PREOPERATIVE AND POSTOPERATIVE SLIPPED PINS WAS 2.5 MM. THE SLIPPED PINS WERE THE UPPER 2 PIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975904 ↗
• MalfunctionMay 7, 2025Device Slipped; Device Slipped

  WORLD NEUROSURGERY (2020) PUBLISHED AN ARTICLE TITLED, "INTRAOPERATIVE HEAD SLIPPAGE WITH THE HEAD CLAMP SYSTEM CAN OCCUR DURING EPILEPTIC SURGERY." THIS IS 2 OF 3 REPORTS FOR PATIENT #1 OF TABLE 2 OF THE LITERATURE AND LINKED TO MFG REPORT NUMBERS 3004608878-2025-00084 AND 3004608878-2025-00086: BACKGROUND - DURING NEUROSURGERY, WE USE A HEAD CLAMP SYSTEM FOR FIRM HEAD FIXATION. HOWEVER, WE HAVE ENCOUNTERED SLIPPAGE USING THE HEAD CLAMP SYSTEM, ALTHOUGH THIS HAS NOT BEEN ADEQUATELY STUDIED. IN THE PRESENT STUDY, TO INCREASE THE RELIABILITY OF THE ANALYSIS USING A MORE HOMOGENEOUS TYPE OF PATIENT DATA, WE CONDUCTED A PROSPECTIVE STUDY OF PATIENTS WHO HAD UNDERGONE EPILEPTIC SURGERY. WE EXAMINED THE POTENTIAL RISK FACTORS FOR HEAD SLIPPAGE AND POSTULATED THAT THE LOCATION OF THE PINS MIGHT BE IMPORTANT. PATIENTS - THE PARTICIPANTS WERE JAPANESE PATIENTS WHO HAD BEEN TREATED FROM (B)(6) 2019 TO (B)(6) 2020 AT THE COMPREHENSIVE EPILEPSY CENTER, SEIREI HAMAMATSU GENERAL HOSPITAL. MALFUNCTION - HEAD SLIPPAGE HAD OCCURRED IN 3 OF THE 21 PATIENTS (14.3°/O; TABLE 2). THE DISTANCE BETWEEN THE PREOPERATIVE AND POSTOPERATIVE SLIPPED PINS WAS 2.5 MM. THE SLIPPED PINS WERE THE UPPER 2 PINS BUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975840 ↗
• MalfunctionApr 23, 2025Device Slipped; Device Slipped

  THERAPEUTICS AND CLINICAL RISK MANAGEMENT (2020:16) PUBLISHED AN ARTICLE TITLED: "ESTIMATION OF RISK FACTORS FOR HEAD SLIPPAGE USING A HEAD CLAMP SYSTEM. A RETROSPECTIVE STUDY." THIS REPORT IS FOR PATIENT #3 OF 3 (MALE, AGE 64, UNDERWENT TUMOR BIOPSY) AND LINKED TO MFG REPORT NUMBERS 3004608878-2025-00062 AND 3004608878-2025-00069: BACKGROUND - ALTHOUGH COMPLICATIONS HAVE BEEN ASSOCIATED WITH HEAD CLAMP SYSTEMS, FEW REPORTS HAVE DESCRIBED HEAD SLIPPAGE. THE PRESENT STUDY AIMED TO DETERMINE RISK FACTORS FOR HEAD SLIPPAGE AND SPECULATED THAT THE POSITION OF HEAD HOLDER PINS MIGHT BE ASSOCIATED. SUMMARY - IN A PROSPECTIVE, CROSS-SECTIONAL, NONRANDOMIZED STUDY BY SAKAKURA ET AL (2020),16 THE OBJECTIVE OF THE STUDY WAS TO COMPARE THE LOCATION OF PINS PRE- AND POSTOPERATIVELY ON CT IMAGES IN CASES OF HEAD SLIPPAGE. CT IMAGES WERE OBTAINED WITH A RADIOLUCENT CARBON MAYFIELD 3-PIN HEAD HOLDER (INFINITY XR2 RADIOLUCENT SYSTEM). TWENTY-ONE PATIENTS WERE INCLUDED (MEAN AGE AT SURGERY: 21±12.81 YEARS; SEX: 15 MALES, SIX FEMALES). INDICATIONS FOR SURGERY INCLUDED ELECTRODE IMPLANTATION (61.9%), EPILEPTIC FOCUS RESECTION (23.8%), AND EPILEPTIC DISCONNECTION (14.3%). HEAD SLIPPAGE WAS OBSERVED IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893743 ↗
• MalfunctionApr 23, 2025Device Slipped; Device Slipped

  THERAPEUTICS AND CLINICAL RISK MANAGEMENT (2020:16) PUBLISHED AN ARTICLE TITLED: "ESTIMATION OF RISK FACTORS FOR HEAD SLIPPAGE USING A HEAD CLAMP SYSTEM. A RETROSPECTIVE STUDY" THIS REPORT IS FOR PATIENT #2 OF 3 (MALE, AGE 23, UNDERWENT EPILEPTICAL DISCONNECTION PROCEDURE) AND LINKED TO MFG REPORT NUMBERS 3004608878-2025-00062 AND 3004608878-2025-00070: BACKGROUND: ALTHOUGH COMPLICATIONS HAVE BEEN ASSOCIATED WITH HEAD CLAMP SYSTEMS, FEW REPORTS HAVE DESCRIBED HEAD SLIPPAGE. THE PRESENT STUDY AIMED TO DETERMINE RISK FACTORS FOR HEAD SLIPPAGE AND SPECULATED THAT THE POSITION OF HEAD HOLDER PINS MIGHT BE ASSOCIATED. SUMMARY - IN A PROSPECTIVE, CROSS-SECTIONAL, NONRANDOMIZED STUDY BY SAKAKURA ET AL (2020),16 THE OBJECTIVE OF THE STUDY WAS TO COMPARE THE LOCATION OF PINS PRE- AND POSTOPERATIVELY ON CT IMAGES IN CASES OF HEAD SLIPPAGE. CT IMAGES WERE OBTAINED WITH A RADIOLUCENT CARBON MAYFIELD 3-PIN HEAD HOLDER (INFINITY XR2 RADIOLUCENT SYSTEM). TWENTY-ONE PATIENTS WERE INCLUDED (MEAN AGE AT SURGERY: 21±12.81 YEARS; SEX: 15 MALES, SIX FEMALES). INDICATIONS FOR SURGERY INCLUDED ELECTRODE IMPLANTATION (61.9%), EPILEPTIC FOCUS RESECTION (23.8%), AND EPILEPTIC DISCONNECTION (14.3%). HEAD SLI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893425 ↗
• MalfunctionApr 23, 2025Device Slipped; Device Slipped

  THERAPEUTICS AND CLINICAL RISK MANAGEMENT (2020:16) PUBLISHED AN ARTICLE TITLED: "ESTIMATION OF RISK FACTORS FOR HEAD SLIPPAGE USING A HEAD CLAMP SYSTEM. A RETROSPECTIVE STUDY". THIS REPORT IS FOR PATIENT #1 OF 3 (MALE, AGE 59, UNDERWENT TRANSNASAL TUMOR REMOVAL) AND LINKED TO MFG REPORT NUMBERS 3004608878-2025-00069 AND 3004608878-2025-00070: BACKGROUND - ALTHOUGH COMPLICATIONS HAVE BEEN ASSOCIATED WITH HEAD CLAMP SYSTEMS, FEW REPORTS HAVE DESCRIBED HEAD SLIPPAGE. THE PRESENT STUDY AIMED TO DETERMINE RISK FACTORS FOR HEAD SLIPPAGE AND SPECULATED THAT THE POSITION OF HEAD HOLDER PINS MIGHT BE ASSOCIATED. SUMMARY - IN A PROSPECTIVE, CROSS-SECTIONAL, NONRANDOMIZED STUDY BY SAKAKURA ET AL (2020),16 THE OBJECTIVE OF THE STUDY WAS TO COMPARE THE LOCATION OF PINS PRE- AND POSTOPERATIVELY ON CT IMAGES IN CASES OF HEAD SLIPPAGE. CT IMAGES WERE OBTAINED WITH A RADIOLUCENT CARBON MAYFIELD 3-PIN HEAD HOLDER (INFINITY XR2 RADIOLUCENT SYSTEM). TWENTY-ONE PATIENTS WERE INCLUDED (MEAN AGE AT SURGERY: 21±12.81 YEARS; SEX: 15 MALES, SIX FEMALES). INDICATIONS FOR SURGERY INCLUDED ELECTRODE IMPLANTATION (61.9%), EPILEPTIC FOCUS RESECTION (23.8%), AND EPILEPTIC DISCONNECTION (14.3%). HEAD SLIPPAGE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891389 ↗
• InjuryJan 8, 2025Device Slipped; Device Slipped

  A FACILITY REPORTED THAT THE PATIENT SLIPPED OUT OF THE MAYFIELD INFINITY XR2 SKULL CLAMP (A2114) DURING A CRANIOTOMY PROCEDURE CAUSING A 3 TO 4CM HEAD LACERATION THAT HAD TO BE WASHED OUT AND CLEANED WITH BETADINE, THEN SUTURED. PATIENT WAS IN PRONE POSITION DURING POSITIONING. THE SKULL CLAMP WAS REMOVED FROM CIRCULATION AND A DIFFERENT SKULL CLAMP WAS USED TO COMPLETE THE CASE. THE PATIENT LEFT THE OR IN STABLE CONDITION. NO SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 21106010 ↗
• MalfunctionJan 3, 2025Unstable; Unstable

  A FACILITY REPORTED THAT DURING A POSTERIOR CERVICAL FUSION CASE, THE ROCKER ARM ON THE MAYFIELD INFINITY SKULL CLAMP (A2114) MOVED WHILE THE PATIENT'S HEAD WAS IN PLACE. THE SKULL CLAMP WAS LOCKING, BUT UNLOCKED TOO EASILY. THERE WAS NO SURGICAL DELAY AND NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: 1. WHEN WAS THE DATE OF THE INCIDENT? ANSWER: BEFORE (B)(6) 2024. 2. WHAT ACTION WAS TAKEN AFTER PRODUCT PROBLEM OCCURRED? ANSWER: REP. CALLED, LOANER RECEIVED, (THE LOANER BROKE WEEK AGO FRIDAY (B)(6), BOTTOM BUTTON DOESN'T LOCK) WE DO NOT HAVE A REPLACEMENT AT THIS TIME. THIS IS A PROBLEM. 3. WHEN WAS THE PRODUCT PROBLEM DISCOVERED (DURING INSPECTION, BEFORE/DURING/AFTER A PROCEDURE)? ANSWER: CLAMP WAS LOCKING, BUT UNLOCKED TOO EASILY. CLAMP WAS LOCKED AND SECURED WITH THIS PATIENT, SURGEON CONFIRMED IT TO BE SAFE TO USE FOR THIS PATIENT, BUT WANTED THE C-CLAMP TO BE SENT AND CHECKED ON PRESSURE, AS IT IS ON A PATIENT TO RECREATE THE SLIPPING OF THE LOCKING SYSTEM OF THE CLAMP. THE LOCK IS THE ONE BY THE 2 SKULL PINS. THAT PIECE WAS PUSHED IN PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074625 ↗
• InjuryDec 27, 2024Unstable; Unstable

  N/A.

  Patient problems: Laceration(s)

  MAUDE report 21027326 ↗
• MalfunctionNov 15, 2024Device Slipped; Device Slipped

  A FACILITY REPORTED THAT DURING A "CRANIOTOMY FOR ANEURYSM REPAIR" CASE, THE PATIENT'S HEAD SLIPPED IN THE MAYFIELD INFINITY XR2 SKULL CLAMP (A2114). THE SLIP HAPPENED AT THE END OF THE SURGERY WHILE THEY WERE CLOSING. THE CIRCULATING NURSE HELD THE PATIENT'S HEAD WHILE THE DOCTOR CLOSED TO ENSURE THERE WAS NO FURTHER SLIPPING. THERE WAS NO PATIENT INJURY AND NO INCREASED SURGERY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20699154 ↗
• InjuryAug 10, 2024Device Slipped; Device Slipped

  A FACILITY REPORTED THAT THE PATIENT'S HEAD SLIPPED IN THE MAYFIELD INFINITY XR2 SKULL CLAMP (A2114) CAUSING A LACERATION THAT HAD TO BE WASHED OUT AND CLEANED WITH BETADINE, THEN SUTURED. THE PATIENT WAS IN PRONE POSITION WHEN THE PINS SLIPPED AT 70 POUNDS OF PRESSURE. ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: 1. PLEASE PROVIDE THE SIZE AND LOCATION OF THE LACERATION. >> THE LACERATION WAS NOT MEASURED PER THE OP NOTE. 2. WHAT TYPE OF PROCEDURE/SURGERY WAS PERFORMED DURING THE INCIDENT? >> - SUBOCCIPITAL CRANIOTOMY FOR RESECTION OF CEREBELLAR ARTERIOVENOUS MALFORMATION - FRAMELESS, STEREOTACTIC, IMAGE-GUIDED, INTRADURAL NEURONAVIGATION - USE OF OPERATING MICROSCOPE FOR ARACHNOIDAL AND ANEURYSMAL MICRODISSECTION - INTRAOPERATIVE DIGITAL SUBTRACTION CEREBRAL ANGIOGRAM 3. WAS THERE A DELAY IN SURGERY DUE TO PRODUCT PROBLEM? IF YES, HOW LONG (IN MINUTES)? >> ABOUT 45 MINUTES DELAY DUE TO PATIENT REPOSITIONING AND SUTURING OF LACERATION. 4. HOW WAS THE PROCEDURE COMPLETED? >>THE PATIENT WAS IN PRONE POSITION WHEN THE PINS SLIPPED, PATIENT¿S LACERATIONS WERE SUTURED AND THE PATIENT WAS REPOSITIONED. SURGERY PROCEEDED AND WAS COMPLETED. 5. PLEASE PROVIDE PATIENT OUTCOME. >> PATIENT

  Patient problems: Laceration(s)

  MAUDE report 19957540 ↗
• InjuryFeb 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPORTED THAT DURING SPINE SURGERY, A STAFF MEMBER WAS TRANSFERRING THE PATIENT PINNED IN THE MAYFIELD INFINITY XR2 SKULL CLAMP (A2114) FROM THE TRANSPORT BED AND WHEN THEY ATTEMPTED TO TURN THE PATIENT FROM SUPINE TO PRONE POSITION, THE PLUNGER DISENGAGED. THIS CAUSED THE PATIENT'S HEAD TO SLIP OUT OF THE PINS RESULTING IN A MINOR SUPERFICIAL LACERATION THAT DID NOT REQUIRE STITCHES. THERE WERE SLIGHT CHANGES IN THE PATIENT'S VITAL SIGNS AS PER NEURO MONITORING FOLLOWING THE INCIDENT, PROMPTING THE ANESTHESIOLOGIST TO REQUEST TO ABORT THE CASE. NO SURGICAL DELAY HAVE BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: ANESTHESIA ASK TO ABORT THE CASE". WAS THE PROCEDURE CANCELLED, OR WAS IT RESCHEDULED TO ANOTHER DATE? "I DO NOT HAVE ANY FURTHER INFORMATION. ALL THE INFORMATION WRITTEN ON THE PAPER IS ALL I GOT."

  Patient problems: Laceration(s)

  MAUDE report 18764502 ↗
• InjuryMar 23, 2023Device Slipped; Device Slipped

  A FACILITY REPORTED THAT DURING A CRANIAL ANEURYSM PROCEDURE, THE MAYFIELD INFINITY XR2 SKULL CLAMP (A2114) SLIPPED CAUSING A SUPERFICIAL LACERATION TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PIN DID SHIFT INTO THE STERILE FIELD, AND THAT WHEN THIS WAS DISCOVERED, THEY REMOVED THE PINS FROM THE PATIENT'S HEAD AND RESTED IT ON THE HEADBOARD AS THEY CLOSED THE PATIENT. THIS WAS DISCOVERED AT THE END OF CASE; THE SHIFT MUST HAVE HAPPENED EARLY IN THE CASE AND THEY THOUGHT THE PATIENT HAD COUGHED. THERE WAS NO DELAY IN THE PROCEDURE AS IT HAPPENED INTRAOPERATIVELY.

  Patient problems: Laceration(s)

  MAUDE report 16598554 ↗
• InjuryJan 6, 2023Mechanical Problem; Device Slipped; Mechanical Problem; Device Slipped

  MDR REPORT # MW5113765 WAS RECEIVED ON 16DEC2022 WITH THE FOLLOWING INFORMATION: "MAYFIELD HEAD CLAMP NOT ABLE TO MAINTAIN PRESSURE, SLIPPED WITH HEAD IN PINS CAUSED LACERATION TO SCALP, INCREASED BLEEDING, ADDITIONAL NEED FOR WOUND CLOSURE." ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 16114295 ↗
• MalfunctionDec 13, 2022Device Slipped; Device Slipped

  A FACILITY REPORTED THAT A PATIENT SLIPPED ON MAYFIELD INFINITY XR2 SKULL CLAMP (A2114) AND PATIENT INJURY RESULTED. THE NATURE OF THE INJURY IS UNKNOWN. NO SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971893 ↗
• InjuryDec 9, 2022Device Slipped; Device Slipped

  A NEURO COORDINATOR REPORTED THAT THE MAYFIELD INFINITY SKULL CLAMP (A2114) WAS USED FOR A CRANIOTOMY PROCEDURE. PATIENT¿S HEAD SLIPPED AND SUSTAINED A 1INCH LACERATION WHICH WAS SUTURED TO CLOSE. PATIENT WAS POSITIONED PRONE AND DID NOT CHANGE POSITION. THE SKULL CLAMP WAS REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Laceration(s)

  MAUDE report 15955349 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT THE PATIENT MOVED AND WAS CUT WHEN PLACED IN THE MAYFIELD INFINITY XR2 SKULL CLAMP (A2114). NO DELAY IN SURGERY HAS BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING PATIENT INJURY.

  Patient problems: Laceration(s)

  MAUDE report 15827998 ↗
• InjuryNov 18, 2022Mechanics Altered; Mechanics Altered

  MEDWATCH UF/ IMPORTER REPORT # (B)(4) WAS RECEIVED WITH THE FOLLOWING INFORMATION: "DURING TURNING THE PATIENT TO THE PRONE POSITION ON THE JACKSON TABLE, THE MAYFIELD RADIOLUCENT HEADFRAME CAME UNLOCKED. THE PINS THAT ATTACHED THE HEADPIECE TO THE PATIENT'S HEAD CAME UNDONE CAUSING A LACERATION TO THE PATIENT'S HEAD AND THE SCRUB TECH'S HAND. FORTUNATELY, THE SURGEON WAS SUPPORTING THE PATIENT'S HEAD DURING THE OCCURRENCE, SO NO MORE INJURY WAS CASED TO THE PATIENT. THIS WAS AFTER THE HEADPIECE HAD BEEN SENT OUT TO THE MANUFACTURER A FOURTH TIME FOR REPAIR. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? C1-C2 POSTERIOR FUSION". ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE FACILITY AS FOLLOWS: PLEASE PROVIDE THE SIZE OF THE LACERATION: ABOUT 4 INCH LACERATION. WAS THERE A DELAY IN SURGERY DUE TO PRODUCT PROBLEM? IF YES, HOW LONG? IT CAUSED A 30 MINUTE DELAY IN THE CASE WHILE WE WERE CHANGING OR BEDS. IS THE DEVICE AVAILABLE FOR EVALUATION? DEVICE IS IN MY OFFICE FOR EVALUATION.

  Patient problems: Laceration(s)

  MAUDE report 15827478 ↗
• InjuryNov 9, 2022Device Slipped; Mechanics Altered; Device Slipped; Mechanics Altered

  A FACILITY REPORTED THAT DURING A CRANIOTOMY PROCEDURE, MAYFIELD INFINITY XR2 SKULL CLAMP (A2114) SLIPPED. THE MAYFIELD WAS IN PLACE ON PATIENT WITH THE ROTATION LOCKED IN PLACE AND PRESSURE GAUGE SET AT 80 POUNDS ON THE PIN, BUT WHILE POSITIONING THE PATIENT PRONE, THE MAYFIELD SWUNG LOOSE AND THE RATCHETING SYSTEM ALSO CAME APART CAUSING SCALP LACERATION TO THE PATIENT. THE LACERATION WAS CLOSED WITH STAPLES AND PATIENT WAS RE-PINNED AND REPOSITIONED WITH A DIFFERENT MAYFIELD. PATIENT OUTCOME REPORTED AS DOING FINE BUT HAS A BIG LACERATION ON HER SCALP.

  Patient problems: Laceration(s)

  MAUDE report 15764922 ↗
• MalfunctionJul 13, 2022Break; Break

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3004608878-2022-00143: A FACILITY REPORTED THAT DURING AN UNSPECIFIED SURGERY, WHEN CLAMPING THE HEAD, THE LOCKING SCREW ON THE MAYFIELD SWIVEL ADAPTER THAT CONNECTS THE MAYFIELD INFINITY XR2 BASE UNIT (A2114) AND THE HEAD MOUNT BROKE. THE PATIENT'S HEAD WAS THUS FREELY MOVABLE AND WAS SECURED BY THE BEDDING ORDERLY TO AVOID INJURIES. NO SERIOUS CONSEQUENCES FOR THE PATIENT WERE OBSERVED. THE EVENT LED TO INCREASED SURGERY TIME OF 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001918 ↗