Neocis Guidance System DRW-1000-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00810004900004), received between Mar 25, 2019 and Jul 1, 2026 — classified as 76 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K161399); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Imprecision

  IT WAS REPORTED THAT AFTER A DENTAL IMPLANT PROCEDURE WITH YOMI, THE PATIENT REPORTED NUMBNESS AROUND THE IMPLANT SITE. FOLLOW-UP WITH THE CUSTOMER NOTED THE PATIENT REMAINS SYMPTOMATIC AND NO MEDICAL INTERVENTION WAS PLANNED AT THIS TIME. THE YOMI SYSTEM WAS USED FOR SURGICAL PLANNING AND OSTEOTOMIES, BUT THE IMPLANTS WERE NOT PLACED WITH ROBOTIC GUIDANCE.

  Patient problems: Numbness

  MAUDE report 25681057 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE IMPLANTS FAILED AFTER ROBOTIC PLACEMENT. NO ADDITIONAL INFORMATION COULD BE OBTAINED ASSOCIATED WITH THE CASE OR PATIENT OUTCOME.

  Patient problems: Failure of Implant

  MAUDE report 23103039 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE IMPLANT FAILED AFTER ROBOTIC PLACEMENT. THE AREA WAS GRAFTED, AND THE IMPLANT WAS REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 23103038 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE IMPLANT FAILED AFTER ROBOTIC PLACEMENT. THE IMPLANT WAS REMOVED AND THE AREA WAS GRAFTED. THE PATIENT WAS SCHEDULED TO RETURN FOR A NEW IMPLANT PLACEMENT.

  Patient problems: Failure of Implant

  MAUDE report 23103020 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIOR TO THE ROBOTIC PROCEDURE AND FOLLOWING ADMINISTRATION OF ANESTHESIA, THE PATIENT'S HEART RATE DROPPED. THE USER REMOVED THE YOMILINK BONE QUICKLY AND CALLED EMERGENCY SERVICES. THE PATIENT WAS TAKEN TO THE HOSPITAL AND STABILIZED. NO FURTHER INJURIES OR MEDICAL INTERVENTION WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 23094726 ↗
• InjuryJun 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AFTER DENTAL IMPLANT PROCEDURE WITH YOMI, THE PATIENT REPORTED NUMBNESS AT THE IMPLANT SITE. FOLLOW-UP WITH THE DENTIST NOTED THE PATIENT REPORTED DYSESTHESIA, AND NO MEDICAL INTERVENTION WAS PLANNED AT THIS TIME. BASED ON THE INVESTIGATION RESULTS, THERE WAS NO INDICATION OF CONTACT WITH THE PLANNED NERVE DURING THE USE OF THE DEVICE. A REVIEW OF FINAL PLACEMENT CONCLUDED THAT THE IMPLANTS WERE PLACED OUTSIDE OF THE PLANNED PATH, YET THE IMPLANTS WERE NOT PLACED WITH ROBOTIC GUIDANCE, AND A DIFFERENT IMPLANT SIZE WAS PLACED FREEHAND WHEN COMPARED TO THE PLAN.

  Patient problems: Nerve Damage

  MAUDE report 22211800 ↗
• InjuryJan 10, 2025Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT DURING A DENTAL IMPLANT PROCEDURE WITH THE NEOCIS GUIDANCE SYSTEM (NGS), THE SURGEON ATTEMPTED A VERTICAL SINUS LIFT WITH INCREASED IMPLANT HEIGHT BY 3MM USING DRILLS IN REVERSE. DURING THE PROCEDURE, THE SINUS MEMBRANE RESISTANCE WAS NOT FELT RESULTING IN PERFORATION. THE SURGEON BONE GRAFTED AND SUTURED THE SITE TO PREVENT FURTHER INJURY. THE IMPLANT WAS NOT PLACED AND THE PATIENT WILL RETURN AT A LATER DATE FOR THE IMPLANT PLACEMENT. NO ADDITIONAL INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. THE PROCEDURE IS NOT AN APPROVED INDICATION FOR USE. THIS ISSUE IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

  Patient problems: Sinus Perforation

  MAUDE report 21132310 ↗
• InjuryOct 30, 2024Calibration Problem; Calibration Problem

  AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS NOT IN THE LOCATION EXPECTED BY THE USER COMPARED TO THE SURGICAL PLAN. A POST-OPERATIVE ASSESSMENT WITH THE SYSTEM'S LOG FILES WAS COMPLETED AND A SYSTEM ACCURACY CHECK WAS COMPLETED. A DEFINITIVE ROOT CAUSE FOR THE INACCURACY REPORTED COULD NOT BE DETERMINED, THERE WAS NO INDICATION OF A DEVICE MALFUNCTION BASED ON INVESTIGATION. THE SURGEON REMOVED THE IMPLANT AND REPLACED IT BY HAND. NO FURTHER MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS ISSUE. THE HANDPIECE IS A STANDARD 3RD PARTY INSTRUMENT USED WITH YOMI NOT MANUFACTURED BY NEOCIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570931 ↗
• InjuryOct 16, 2024Calibration Problem; Calibration Problem

  AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS BUCCAL COMPARED TO THE SURGICAL PLAN. A POST-OPERATIVE ASSESSMENT WITH THE SYSTEM'S LOG FILES WAS COMPLETED AND A SYSTEM ACCURACY CHECK WAS COMPLETED. A DEFINITIVE ROOT CAUSE FOR THE INACCURACY REPORTED COULD NOT BE DETERMINED, THERE WAS NO INDICATION OF A DEVICE MALFUNCTION BASED ON INVESTIGATION. THE SURGEON REMOVED THE IMPLANT AND REPLACED IT BY HAND. NO FURTHER MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS ISSUE. THE HANDPIECE IS A STANDARD 3RD PARTY INSTRUMENT USED WITH YOMI NOT MANUFACTURED BY NEOCIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465156 ↗
• InjuryOct 16, 2024Calibration Problem; Calibration Problem

  AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS BUCCAL COMPARED TO THE SURGICAL PLAN. A POST-OPERATIVE ASSESSMENT WITH THE SYSTEM'S LOG FILES WAS COMPLETED AND A SYSTEM ACCURACY CHECK WAS COMPLETED. A DEFINITIVE ROOT CAUSE FOR THE INACCURACY REPORTED COULD NOT BE DETERMINED, THERE WAS NO INDICATION OF A DEVICE MALFUNCTION BASED ON INVESTIGATION. THE SURGEON REMOVED THE IMPLANT AND REPLACED IT BY HAND. NO FURTHER MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS ISSUE. THE HANDPIECE IS A STANDARD 3RD PARTY INSTRUMENT USED WITH YOMI NOT MANUFACTURED BY NEOCIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20465135 ↗
• InjuryAug 22, 2024Use of Device Problem; Use of Device Problem

  AFTER GUIDED PROCEDURE FOR AN EDENTULOUS REGION WITH A NARROW RIDGE, IT WAS FOUND THAT THE IMPLANT PENETRATED THE BUCCAL PLATE. THE USER REMOVED THE IMPLANT AND PLACED IT AT A SEPARATE LOCATION BY HAND. A REVIEW OF THE YOMI SYSTEM'S LOG FILES DID NOT INDICATE ANY SYSTEM MALFUNCTION. PER REVIEW OF PATIENT SCANS, THE IMPLANT WAS PLANNED AT CLOSE PROXIMITY OF THE BUCCAL PLATE. FURTHER REVIEW WITH THE CUSTOMER INDICATED THAT THE PATIENT'S BONE QUALITY AT THE PLANNED LOCATION MAY HAVE AFFECTED THE EVENT. NO FURTHER INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20025521 ↗
• InjuryJul 2, 2024Calibration Problem; Calibration Problem

  AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS LINGUAL COMPARED TO THE SURGICAL PLAN. A POST-OPERATIVE ASSESSMENT WITH THE SYSTEM'S LOG FILES WAS COMPLETED AND A SYSTEM ACCURACY CHECK WAS COMPLETED. THE LIKELY ROOT CAUSE FOR THE ISSUE WAS ATTRIBUTED TO SKYVING OF THE DRILL BIT. THE SURGEON REMOVED THE IMPLANT AND REPLACED IT BY HAND. NO FURTHER MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS ISSUE. THE HANDPIECE IS A STANDARD 3RD PARTY INSTRUMENT USED WITH YOMI NOT MANUFACTURED BY NEOCIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655234 ↗
• InjuryApr 12, 2024Calibration Problem; Calibration Problem

  TWO DAYS AFTER GUIDED PROCEDURE THE PATIENT RETURNED TO THE SURGEON OFFICE COMPLAINING OF PAIN. A POST-OPERATIVE SCAN REVIEW SHOWED THE IMPLANT 2MM OUTSIDE OF THE PLANNED PATH. A POST-OPERATIVE ASSESSMENT WITH THE SYSTEM'S LOG FILES WAS COMPLETED AND A SYSTEM ACCURACY CHECK WAS COMPLETED. THE LIKELY ROOT CAUSE FOR THE ISSUE WAS ATTRIBUTED TO SKYVING OF THE DRILL BIT. THE SURGEON REMOVED THE IMPLANT, RECONTOURED THE BONE AND REPLACED IT. NO FURTHER MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS ISSUE. THE HANDPIECE IS A STANDARD 3RD PARTY INSTRUMENT USED WITH YOMI NOT MANUFACTURED BY NEOCIS.

  Patient problems: Implant Pain

  MAUDE report 19101243 ↗
• InjuryMar 11, 2024Use of Device Problem; Use of Device Problem

  DURING GUIDED PROCEDURE FOR A PLANNED IMPLANT AT AN EDENTULOUS REGION WITH A NARROW RIDGE, IT WAS FOUND THAT THE DRILL PENETRATED THE BUCCAL PLATE. CLINICAL REVIEW INDICATED THAT THE DRILL HAD DAMAGED THE BUCCAL BONE DURING THE THIRD DRILL SEQUENCE. A REVIEW OF THE YOMI SYSTEM'S LOG FILES DID NOT INDICATE ANY SYSTEM MALFUNCTION. PER REVIEW OF PATIENT SCANS, THE IMPLANT WAS PLANNED WITHIN 1MM OF THE BUCCAL PLATE. THE USER REMOVED THE DRILL AND THE SITE WAS GRAFTED. THE PATIENT LEFT EDENTULOUS UNTIL AN IMPLANT CAN BE PLACED AT A LATER TIME. NO FURTHER INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874386 ↗
• InjuryFeb 23, 2024Use of Device Problem; Use of Device Problem

  AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS OUTSIDE OF THE PLANNED PATH. A POST OPERATIVE ASSESSMENT WITH THE SYSTEM'S LOG FILES WAS COMPLETED. A SLIGHT HANDPIECE ROTATION WAS DETERMINED TO BE THE LIKELY ROOT CAUSE OF THE EVENT AS IT WOULD EXPLAIN THE ERROR DURING THE LANDMARK CHECK AND ALSO WHY PART OF THE IMPLANT WAS OUTSIDE THE BUCCAL WALL. THE SURGEON REMOVED THE IMPLANT AND REPLACED IT. NO FURTHER MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS ISSUE. THE HANDPIECE IS A STANDARD 3RD PARTY INSTRUMENT USED WITH YOMI NOT MANUFACTURED BY NEOCIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18771216 ↗
• InjuryJan 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS NOT ACCORDING TO THE SURGICAL PLAN. AN ANALYSIS OF THE SYSTEM LOG FILES AS WELL AS SERVICING OF THE SYSTEM WERE COMPLETED BUT A ROOT CAUSE OF THE ISSUE COULD NOT BE ESTABLISHED AT THIS TIME. FURTHER INVESTIGATION IS ONGOING WHICH INCLUDES A REVIEW OF THE PROCEDURE'S POST-OP CT RELATIVE TO THE SURGEON'S PRE-OPERATIVE PLAN. A FOLLOW UP MDR WILL BE SUBMITTED ONCE THIS ADDITIONAL INVESTIGATION IS COMPLETED. THIS PARTICULAR REPORT IS BEING FILED IN ADVANCE OF COMPLETING THE INVESTIGATION IN AN ABUNDANCE OF CAUTION TO BE IN COMPLIANCE WITH THE MDR REGULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461281 ↗
• InjuryDec 1, 2023Use of Device Problem; Use of Device Problem

  AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS NOT ACCORDING TO THE SURGICAL PLAN. THE SURGEON UPDATED THE OSTEOTOMY AND COMPLETED THE PROCEDURE IN A FREEHAND MANNER. BASED ON AN ANALYSIS OF THE SYSTEM LOG FILES, IT WAS FOUND THAT THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS THE FIDUCIAL ARRAY WAS NOT CONNECTED PROPERLY BY THE USER DURING THE PATIENT'S PRE-OPERATIVE CT SCAN. A SECURE FIDUCIAL ARRAY DURING THE CT SCAN IS REQUIRED IN ORDER TO ENSURE ACCURATE IMAGE REGISTRATION TO THE PHYSICAL SPACE OF THE PATIENT. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION TO BE IN COMPLIANCE WITH THE MDR REGULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18250492 ↗
• InjuryNov 13, 2023Use of Device Problem; Use of Device Problem

  AFTER A GUIDED PROCEDURE, A NOBEL BIOCARE NOBEL ACTIVE IMPLANT WAS PLACED IN A FLAPLESS MANNER IN THE ANTERIOR MAXILLARY CENTRAL INCISOR LOCATION AND WAS FOUND TO BE OUTSIDE THE BUCCAL PLATE. A REVIEW OF THE YOMI SYSTEM'S LOG FILES DID NOT INDICATE ANY SYSTEM MALFUNCTION. THE IMPLANT'S INSTRUCTIONS FOR USE WERE ALSO REVIEWED WHICH CONTRAINDICATED THE USE OF THIS IMPLANT FOR REPLACING CENTRAL INCISORS IN THE MAXILLA. THIS EVENT IS THEREFORE BEING ATTRIBUTED TO OFF LABEL USE OF THE SPECIFIED IMPLANT MANUFACTURER'S CONTRAINDICATION STATEMENT. THE IMPLANT IS NOT MANUFACTURED BY NEOCIS. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION TO BE IN COMPLIANCE WITH THE MDR REGULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18127907 ↗
• InjuryNov 13, 2023Use of Device Problem; Use of Device Problem

  AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT 1 OF 2 IMPLANT PLACEMENTS PARTIALLY COMPROMISED THE BUCCAL WALL. A POST OPERATIVE ASSESSMENT WITH THE SYSTEM'S LOG FILES WAS COMPLETED. A SLIGHT HANDPIECE ROTATION WAS DETERMINED TO BE THE LIKELY ROOT CAUSE OF THE EVENT AS IT WOULD EXPLAIN THE 1.0 MM ERROR DURING THE LANDMARK CHECK AND ALSO WHY PART OF THE IMPLANT WAS OUTSIDE THE BUCCAL WALL. THE SURGEON REMOVED THE IMPLANT AND REPLACED IT. THERE WERE NO FURTHER ISSUES NOTED WITH THE REPLACED IMPLANT AS WELL AS THE 2ND IMPLANT PLACEMENT. THE HANDPIECE IS A STANDARD 3RD PARTY INSTRUMENT USED WITH YOMI NOT MANUFACTURED BY NEOCIS. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION TO BE IN COMPLIANCE WITH THE MDR REGULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18127880 ↗
• InjuryNov 6, 2023Use of Device Problem; Use of Device Problem

  AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT 1 OF 2 IMPLANT PLACEMENTS WERE NOT ACCORDING TO THE SURGICAL PLAN. ONE IMPLANT WAS PLACED BUCCAL TO PLAN. AN ANALYSIS OF THE SYSTEM LOG FILES AND A POST-OP CT SCAN WAS COMPLETED. SOME CONTRIBUTING FACTORS WERE IDENTIFIED I.E., PATIENT WAS OUTSIDE OF THE RECOMMENDED WORK VOLUME, HOWEVER A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. A QUICK CHECK OF THE SYSTEM WAS ALSO PERFORMED AFTER THE PROCEDURE AND THE SYSTEM WAS FOUND TO BE IN GOOD WORKING ORDER. SUCCESSFUL PROCEDURES HAVE BEEN PERFORMED SINCE THIS EVENT HOWEVER FIELD SERVICE WILL STILL BE CONTACTED TO DETERMINE IF SERVICING OF THE SYSTEM IS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070925 ↗
• InjuryNov 5, 2023Off-Label Use; Off-Label Use

  AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS NOT ACCORDING TO THE SURGICAL PLAN. BASED ON AN ANALYSIS OF THE SYSTEM LOG FILES, IT WAS FOUND THAT THE SYSTEM WAS USED OFF LABEL. SPECIFICALLY, THE SPLINT USED REQUIRES A MINIMUM OF 3 BONE SCREWS TO ENSURE ACCURATE TRACKING OF PATIENT MOVEMENT, HOWEVER THE SURGEON USED ONLY 2 BONE SCREWS. ALTHOUGH THE SPLINT SEEMED STABLE DURING THE PROCEDURE PER FEEDBACK FROM THE FIELD, LIKELY ROOT CAUSE OF THIS EVENT IS SPLINT MOVEMENT DUE TO NOT USING THE REQUIRED MINIMUM OF 3 BONE SCREWS. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION TO BE IN COMPLIANCE WITH THE MDR REGULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070841 ↗
• InjuryNov 5, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AFTER A GUIDED PROCEDURE, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS NOT ACCORDING TO THE SURGICAL PLAN. BASED ON AN ANALYSIS OF THE SYSTEM LOG FILES AND POST-OP CT SCAN, POSSIBLE ROOT CAUSES WERE DETERMINED TO BE THE USER APPLYING TOO MUCH FORCE TO THE HANDPIECE WHILE DRILLING, HANDPIECE ROTATION, AND/OR PATIENT MOVEMENT. THE SURGEON REMOVED ONE OF THE IMPLANTS IN ORDER TO PLACE THE FULL ARCH RESTORATIVE COMPONENTS HOWEVER THE INVESTIGATION WAS INCONCLUSIVE THAT THIS WAS DUE TO THE SYSTEM. THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION TO BE IN COMPLIANCE WITH THE MDR REGULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070819 ↗
• MalfunctionNov 5, 2023Failure to Calibrate; Failure to Calibrate

  AFTER A GUIDED PROCEDURE AND POST-OPERATIVE ASSESSMENT, IT WAS FOUND THAT THE IMPLANT PLACEMENT WAS NOT ACCORDING TO THE SURGICAL PLAN. THE SURGEON REMOVED THE IMPLANT AND RELOCATED IT IN A FREEHAND MANNER. NO FURTHER MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070782 ↗
• InjuryNov 3, 2023Calibration Problem; Calibration Problem

  AFTER A GUIDED PROCEDURE AND POST-OPERATIVE ASSESSMENT, IT WAS FOUND THAT THE IMPLANT PLACEMENT COMPROMISED THE BUCCAL WALL. THE SURGEON REMOVED THE IMPLANT, THE SITE WAS GRAFTED, AND PATIENT WAS SCHEDULED TO COME BACK ANOTHER DAY AND RE DO THE IMPLANT PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18069693 ↗
• InjuryAug 25, 2023Failure to Calibrate; Failure to Calibrate

  DURING A GUIDED PROCEDURE, THE IMPLANTS PLACEMENT COMPROMISED LABIAL PLATE. PATIENT'S RIDGE WAS VERY THIN. THE SURGEON GRAFTED THE SITE AND PLACED A MEMBRANE. NO FURTHER MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17626115 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161399. One submission often covers many models, so check the product and lot details in each record.

• Z-0511-2020 · Oct 4, 2019 · Terminated
  Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (p