mild Device Kit MDK-0001 (UDI B235MDK00010)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI B235MDK00010), received between Dec 27, 2018 and Nov 21, 2024 — classified as 29 injuries.

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 29 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10/31/2024, A VERTOS REPRESENTATIVE REPORTED THAT A FEMALE PATIENT, WHO WAS UNDER TREATMENT FOR A MULTI-LEVEL L3/L4 AND L4/L5 MILD PROCEDURE ON THE SAME DAY, EXHIBITED EVIDENCE OF A CSF LEAK DURING THE PROCEDURE. THE OPERATING PHYSICIAN CONFIRMED THAT THE DURA WAS PUNCTURED DURING TREATMENT WHILE USING THE MILD DEVICE KIT, RESULTING IN THE CSF LEAK. THE PATIENT DID NOT SHOW ANY SYMPTOMS BEYOND THE CSF LEAK WHILE SHE REMAINED LAYING DOWN ON THE OPERATING TABLE, BUT DID EXPERIENCE HEADACHES SITTING UP SOON AFTER THE PROCEDURE. A BLOOD PATCH WAS PERFORMED TO REMEDY THE DURA PUNCTURE FOLLOWING THE MILD PROCEDURE, AND THE PATIENT WAS DISCHARGED ABOUT AN HOUR AFTER THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED TO HAVE A POST LUMBAR SPINAL FUSION AT THE L4/L5 LEVEL PRIOR TO THE MILD PROCEDURE, BUT OTHERWISE OBSERVED WITH NO OTHER UNUSUAL ANATOMY. THERE HAVE BEEN NO FURTHER POST-OPERATIVE SYMPTOMS FROM THE PATIENT REPORTED FOLLOWING HER DISCHARGE FROM THE HOSPITAL.

  Patient problems: Cerebrospinal Fluid Leakage; Dural Tear

  MAUDE report 20748208 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, A 73 YEAR-OLD FEMALE PATIENT HAD A MILD PROCEDURE PERFORMED ON L2-L3 AND L3-L4, FOLLOWED BY AN EPIDURAL STEROID INJECTION AT THE SAME LEVELS. IMMEDIATELY FOLLOWING THE PROCEDURE, SHE NOTED SEVERE LOWER BACK AND RIGHT LEG PAIN. AN MRI WAS DONE AND WAS INCONCLUSIVE. A CET WITH MYELOGRAM SHOWED AN L1-L2 EPIDURAL HEMATOMA. THE PATIENT HAD TWO DECOMPRESSION LAMINECTOMIES PERFORMED BY A NEUROSURGEON FOLLOWING THE MILD PROCEDURE AND WAS PLACED IN AN INPATIENT REHAB TO RECOVER. THE PATIENT HISTORY PRIOR TO THE MILD PROCEDURE INCLUDED A FUSION AT L4-L5 WITH POSTERIOR INSTRUMENTATION AND SPINAL CORD STIMULATOR WITH ANCHORS OVERLYING THE RIGHT L2-L3 AND L3-L4 INTERSPACE.

  Patient problems: Hematoma

  MAUDE report 20293200 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, AN 88 YEAR-OLD MALE PATIENT HAD A MILD PROCEDURE PERFORMED. FOLLOWING THE PROCEDURE, THE PATIENT WENT TO THE HOSPITAL FOR LEG PAIN AND WAS DIAGNOSED WITH AN EPIDURAL HEMATOMA. THE PATIENT WAS TREATED FOR THE INITIAL HEMATOMA, AND THEN AGAIN FOR A SECOND HEMATOMA THAT HAD DEVELOPED. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE PATIENT HAS MADE A FULL RECOVERY. THE PHYSICIAN REPORTED THAT THE PATIENT'S HISTORY WAS BELIEVED TO BE THE CAUSE OF THE HEMATOMA, AS THE PATIENT WAS ON BLOOD THINNERS AND WAS REPORTED TO BE SUFFERING FROM ALCOHOLISM.

  Patient problems: Hematoma

  MAUDE report 20292992 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A 71 YO MALE PATIENT HAD A BILATERIAL L-3-L4, L4-L5 MILD PROCEDURE. ON 8/23/2024, A VERTOS REPRESENTATIVE WAS CONTACTED BY THE TREATING PHYSICIAN WHO REPORTED THAT THE PATIENT HAD PAIN WHEN BENT OVER AND NUMBNESS IN THE LEG 4-6 HOURS AFTER THE PROCEDURE AND WENT TO THE HOSPITAL ON (B)(6) 2024. AN MRI SCAN SHOWED A HEMATOMA ON THE LEFT SIDE OF L3-L4. THE PATIENT WAS REFERRED TO A SURGEON AND UNDERWENT A SUCCESSFUL LAMINECTOMY ON (B)(6) 2024. PATIENT'S SPINE WAS FUSED FROM T10-S1.

  Patient problems: Hematoma

  MAUDE report 20257470 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WHO WAS TREATED ON 6/25 WITH A BILATERAL L3-L4 MILD PROCEDURE, WAS SEEN IN OFFICE BY THE TREATING PHYSICIAN AS FOLLOW-UP ON 7/22 WITH SITE TENDERNESS, FLUCTUANT, AND DRAINAGE WAS DETERMINED TO HAVE DEVELOPED AN INFECTION. AN MRI WITH CONTRAST SHOWED 9MM SUBCUTANEOUS ENHANCING COLLECTION CONCERNING FOR ACCESS AT THE L4-5 LEVEL WITH EXTENSION OF INFLAMMATION INTO THE BILATERAL PARASPINAL MUSCLES (R>L). THERE WAS NO CONCERN FOR EXTENSION INTO THE SPINAL CANAL. THE PATIENT'S POST-PROCEDURAL PAIN WAS MANAGEABLE, AND THE PATIENT DENIED EXPERIENCING ANY SYMPTOMS OF FEVERS, CHILLS, WEAKNESS, NUMBNESS, OR INCONTINENCE AFTER THE MILD PROCEDURE. INFORMATION SUCH AS THE PATIENT'S ADHERENCE TO ANY RECOVERY REGIMENT, INCLUDING THE PATIENT'S LAST STEROID USE DURING RECOVERY, DIABETIC STATUS, OR ANY PREVIOUS HEALTH ISSUES WITH POST-PROCEDURAL HEALING OR ONGOING SYSTEMIC INFECTIONS COULD NOT BE OBTAINED. THE PATIENT WAS TREATED IN THE HOSPITAL WITH IV ANTIBIOTICS FOR THE INFECTION AND DISCHARGED ON 7/25A PATIENT WHO WAS TREATED ON 6/25 WITH A BILATERAL L3-L4 MILD PROCEDURE, WAS SEEN IN OFFICE BY THE TREATING PHYSICIAN AS FOLLOW-UP ON 7/22 WITH SITE TENDERNESS, FLUCTUANT, AND DRAINAGE WAS

  Patient problems: Skin Infection

  MAUDE report 20072506 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A FEMALE PATIENT HAD A BILATERAL L3-L4, L4-L5 MILD PROCEDURE PERFORMED USING A STREAMLINE APPROACH WITH EPIDUROGRAM (LEVEL UNKNOWN). NO PROCEDURAL ISSUES WERE NOTED AND PATIENT WAS DISCHARGED TO HOME. FOUR DAYS AFTER THE PROCEDURE, ON (B)(6) 2022, THE PATIENT REPORTED SYMPTOMS OF A CSF LEAK (FLUID OUT OF INCISION SITE AND HEADACHES). THE PATIENT RECEIVED TWO UNSUCCESSFUL BLOOD PATCH ATTEMPTS BY THE TREATING PHYSICIAN AND WAS SENT TO THE NEURO-SURGEON WHO PERFORMED A DURAL SEAL. PATIENT IS REPORTEDLY DOING FINE AFTER THE DURAL SEAL PROCEDURE. THE PATIENT HAD SYMPTOMS OF A CSF LEAK 4 DAYS AFTER THE INITIAL MILD PROCEDURE AND NOTHING REPORTED SHOWS ANY MEDICAL DEVICE FAILURE OR MALFUNCTION OR THAT THE DEVICE CAUSED/CONTRIBUTED TO THIS EVENT.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 19716446 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 12/9/21, A COMPANY REPRESENTATIVE WAS CONTACTED BY TWO PROFESSIONAL ACQUAINTANCES, ONE OF WHOM TOLD OF A RUMOR THAT A MILD PATIENT WAS IN THE EMERGENCY ROOM AT (B)(6) FROM APPARENT COMPLICATIONS. AFTER FURTHER INVESTIGATION, THE COMPANY REP SPOKE TO SOME (B)(6) PHYSICIANS WHO MENTIONED THAT ONE OF THEIR NEUROSURGEONS HAD TREATED A PATIENT POST MILD PROCEDURE. THE REP REPORTED THIS BACK TO A PHYSICIAN CUSTOMER, WHO DOES MILD PROCEDURES AT A FACILITY IN THE (B)(6). THE DR'S OFFICE INVESTIGATED AND FOUND THAT ONE OF HIS PATIENTS HAD A MILD PROCEDURE ON (B)(6) 2021 AND HAD CALLED ABOUT POST-OP PAIN. THE DR. INSTRUCTED THE PATIENT TO GO TO THE EMERGENCY ROOM IF THE PAIN GOT WORSE BUT DID NOT HEAR FURTHER ABOUT WHAT HAPPENED. IN (B)(6) OF 2022, A PROFESSOR IN PAIN MANAGEMENT AT (B)(6) WHO WAS NOT INVOLVED WITH THE PATIENT'S CASE FOLLOWED UP ON THE RUMORS AND SPOKE TO THE DR. AND THE NEUROSURGEON. ACCORDING TO THE PROFESSOR: THE PATIENT HAD BEEN ADMITTED TO THE EMERGENCY ROOM AT (B)(6) ON (B)(6) 2021 WITH MOTOR/SENSORY LOSS, DECREASED MOTOR STRENGTH, AND DORSAL FLEXION OF THE LEFT LEG; THE NEUROSURGEON OFFERED SURGERY BUT THE PATIENT INITIALLY REFUSED; ON (B)(6) 2021, NEUROSURGEON PERF

  Patient problems: Cerebrospinal Fluid Leakage; Muscle Weakness/Atrophy; Paralysis

  MAUDE report 19715644 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, A 74 Y/O FEMALE PATIENT HAD A BILATERAL L4-L5 MILD PROCEDURE. THE PATIENT HAD BEEN ON ANTICOAGULANTS THAT WERE REPORTEDLY STOPPED IN AN APPROPRIATE TIMEINE BEFORE THE PROCEDURE. AN EPIDUROGRAM WAS REPORTED AS PERFORMED AT L3-L4 DUE TO DIFFICULTY ACCESSING THE L4-L5 FOR THE EPIDUROGRAM. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE PERFORMED AS INTENDED. APPROXIMATELY 2 HOURS FOLLOWING THE PROCEDURE, THE PATIENT COMPLAINED OF SEVERE BACK PAIN AND LEG WEAKNESS AND WENT FROM HOME TO THE ER. AN MRI WAS PERFORMED, AND AN EPIDURAL HEMATOMA WAS IDENTIFIED. THE PATENT UNDERWENT SPINE SURGERY AND HAD THE HEMATOMA EVACUATED ONE DAY AFTER THE MILD PROCEDURE. IT WAS REPORTED THAT THE HEMATOMA WAS AT T-11 AND THE MILD PROCEDURE WAS PERFORMED MUCH LOWER AT L4-L5 WITH EPIDUROGRAM AT L3-L4 IN THE LUMBAR SPINE THEREFORE IT CANNOT BE DETERMINED WHAT CAUSED THE HEMATOMA. THE PATIENT RECOVERED AFTER THE UNEVENTFUL SURGERY.

  Patient problems: Hematoma

  MAUDE report 19715635 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A FEMALE PATIENT UNDERWENT A BILATERAL, 2 LEVEL MILD PROCEDURE. AN EPIDUROGRAM WAS PERFORMED AT THE LEVEL ABOVE USING A 20 GAUGE TOUHY NEEDLE. THE PATIENT WAS REPORTED TO BE OF AVERAGE SIZE AND WEIGHT AND STOPPED ALL MEDICATIONS INCLUDING ANTICOAGULANTS 7-10 DAY BEFORE THE PROCEDURE. THE PATIENT HAD ISSUES OF HYPOTENSION DURING THE PROCEDURE AND WAS TREATED WITH 20MG EPHEDRINE AND A 500ML BOLUS OF FLUID. THE PHYSICIAN HAD SOME IMAGING ISSUES DUE TO THE ANATOMY AND SEEING MARKERS THAT RESULTED IN USING MORE THAT 15 MINUTES OF FLUOROSCOPY TIME. THE PATIENT COMPLAINED OF NEUROGENIC CLAUDICATION AND BACK PAIN THE NEXT DAY ( ON (B)(6)2022). AN MRI WAS PERFORMED AND SHOWED "HETEROGENEOUS BILOBED FLUID COLLECTION IN THE DORSAL EPIDURAL SPACE ALONG THE DORSAL THECAL SAC. FLUID COLLECTION REPRESENTED POST OP HEMATOMA GIVEN CHARACTERISTICS". THE PATIENTS PAIN CONTINUED FOR 1 WEEK WHEN A SURGICAL INTERVENTION FOR THE SUBDURAL HEMATOMA WAS PERFORMED ON (B)(6) 2022. THE SURGEON DID NOT FIND A DORSAL EPIDURAL TEAR. THERE WAS AN OSTEOPHYTE NOTED ON THE FACET GOING MEDIALLY WITH A "SMALL VESSEL ABOVE IT THAT MAY HAVE BEEN INJURED DURING THE PROCEDURE" - THIS WAS THEIR BEST GUESS. T

  Patient problems: Hematoma

  MAUDE report 19715571 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 THE PATIENT UNDERWENT A L4-L5 MILD PROCEDURE. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE PERFORMED AS INTENDED. SIX DAYS FOLLOWING THE PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH SEVERE BACK PAIN ON (B)(6) 2020 AND WAS ADMITTED TO THE HOSPITAL. AN MRI SCAN SHOWED A EPIDURAL HEMATOMA AND AS A RESULT A MULTILEVEL LAMINECTOMY WAS PERFORMED. THE PATIENT WAS REPORTED TO BE STABLE WITH NO NEUROLOGIC COMPROMISE AT THE TIME OF THE COMPLAINT INVESTIGATION. IT SHOULD BE NOTED THAT THE PATIENT HAD LEUKEMIA AND HAD BEEN TAKING ELOQUIS THAT WAS STOPPED A WEEK BEFORE THE MILD PROCEDURE.

  Patient problems: Hematoma

  MAUDE report 19715558 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 A PHYSICIAN PERFORMED A BILATERAL L3-L4, L4-L5 MILD PROCEDURE ON A 75Y/O FEMALE PATIENT WITH A HISTORY OF URINARY INCONTINENCE (2008) AND OSTEOARTHRITIS. FROM IMAGING, THE PATIENT WAS NOTED TO HAVE SEVERE STENOSIS, GRADE 1 SPONDYLOLISTHESIS, AND FACET CYST. THE CASE REPORTEDLY WENT WELL. ON (B)(6) 2022 THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO URINARY INCONTINENCE AND NUMBNESS IN THE GENITAL AREA. THE PATIENT WAS PLACED IN THE CARE OF A NEUROSURGEON. AN MRI WAS PERFORMED AND THERE WAS NO EVIDENCE OF AN EPIDURAL HEMATOMA, HOWEVER THE STENOSIS WAS WORSE THAN PRIOR TO THE PROCEDURE. THE PATIENT WAS DIAGNOSED WITH CAUDA EQUINA SYNDROME, A BUCKLED LIGAMENT AT L4-L5, AND UNDERWENT EMERGENT SURGERY. THE PATIENT IS CURRENTLY STABLE, FULL STRENGTH IN LEGS, WORSENED URINARY RETENTION AND HAS IMPROVEMENT IN NUMBNESS. UPDATED REPORT FROM TREATING PHYSICIAN DATED (B)(6) 2022 STATED THAT PATIENT REMAINED IN THE HOSPITAL AND REMAIN FLAT FOR 7 DAYS BEFORE DISCHARGE FOLLOWING THE EMERGENT SURGERY BECAUSE OF A CSF LEAK. AT THE TIME OF THE COMPLAINT INVESTIGATION, THE PATIENT WAS IN REHAB DUE TO ONGOING URINARY INCONTINENCE. THE PHYSICIANS' PATIENT SELECTION AND PRE-PROCEDURE EVALU

  Patient problems: Cerebrospinal Fluid Leakage; Nerve Damage

  MAUDE report 19715435 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A MALE PATIENT HAD A L4-L5 MILD PROCEDURE PERFORMED. AN EPIDURAL WAS PERFORMED WITH THE MILD PROCEDURE AT THE L4-L5 LEVEL. NOTHING ABNORMAL WAS REPORTED REGARDING THE PROCEDURE OR THE PATIENT'S ANATOMY. ONE WEEK POST-OPERATIVE, THE PATIENT WAS EXPERIENCING INCREASED BACK AND LEG PAIN. AN MRI WAS PERFORMED, AND THE PATIENT WAS DIAGNOSED WITH A HEMATOMA NEAR THE TREATMENT AREA OF THE MILD PROCEDURE AT L5-S1. AS OF ON (B)(6) 2024, IT WAS CONFIRMED BY THE PHYSICIAN THAT THE PATIENT HAS NOT RECEIVED ANY INTERVENTIONAL TREATMENT BEYOND BED REST.

  Patient problems: Hematoma; Pain

  MAUDE report 19047620 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A MILD PROCEDURE PERFORMED ON (B)(6) 2024, THE PHYSICIAN OBSERVED CSF LEAKING OUT OF THE MILD PORTAL DEVICE. THE PATIENT'S SPINAL DURA HAD BEEN BREACHED AFTER THE PHYSICIAN HAD UNEXPECTEDLY ADVANCED THE MILD TROCAR DEVICE TOO FAR BY TAPPING THE HANDLE OF THE DEVICE USING HIS PALM, WHICH IS NOT STANDARD PROCEDURE FOR ADVANCING MILD DEVICES IN ACCORDANCE WITH THE PRODUCT IFU.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 19047618 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A MALE PATIENT WITH SOME SCOLIOSIS AND A SMALL SPONDYLOLISTHESIS HAD A BILATERAL L1-L2 MILD PROCEDURE PERFORMED. AN EPIDURAL WAS PERFORMED WITH THE MILD PROCEDURE. NOTHING ABNORMAL WAS REPORTED REGARDING THE PROCEDURE. THE PATIENT HAD ALSO REPORTEDLY STOPPED THEIR ANTICOAGULANTS IN AN APPROPRIATE TIMELINE PRIOR TO SURGERY. THE PATIENT WOKE FROM THE PROCEDURE WITH EXCRUCIATING GROIN PAIN. THE PHYSICIAN STATED THAT THE PATIENT HAD NO MOTOR DEFICITS AND WAS ABLE TO WALK OUT OF THE SURGERY CENTER. THE PHYSICIAN RECOMMENDED THAT THE PATIENT SHOULD BE SEEN IN THE ER AFTER DISCHARGE. AN MRI WAS PERFORMED AND SHOWED BLOOD AROUND THE TREATMENT AREA OF THE MILD PROCEDURE AND AN EMERGENCY LAMINECTOMY WAS PERFORMED. THE PATIENT WAS HOSPITALIZED BECAUSE OF THIS EVENT. THE PATIENTS' PAIN HAS IMPROVED POST LAMINECTOMY ACCORDING TO THE PHYSICIAN.

  Patient problems: Hematoma; Pain

  MAUDE report 18899489 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VERTOS MEDICAL WAS MADE AWARE OF A PUBLISHED MEDICAL JOURNAL ARTICLE DATED 12/25/2023, IN WHICH A 76 YEAR OLD FEMALE PATIENT WAS REPORTED TO HAVE POST-PROCEDURAL COMPLICATIONS IMMEDIATELY FOLLOWING A LEFT L2/L3 MILD PROCEDURE, INCLUSIVE OF LOWER BACK/SACRAL PAIN AND LOWER EXTREMITY WEAKNESS RESULTING FROM AN ACUTE EPIDURAL HEMATOMA. THE ARTICLE STATES THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM FOR SURGICAL EVACUATION, WHICH RESULTED IN A GOOD OUTCOME WITHOUT ANY FURTHER COMPLICATIONS. THERE WAS NO INFORMATION IN THE ARTICLE RELATED TO THE MILD PROCEDURE, INCLUSIVE OF ANY DEVICE TRACEABILITY, OPERATING FACILITY, OPERATING PHYSICIAN, AND THE EVENT DATE. VERTOS MEDICAL ATTEMPTED TO OBTAIN SUCH INFORMATION FROM THE ARTICLE AUTHORS; HOWEVER, THE AUTHORS COULD NOT PROVIDE ANY INFORMATION IN ACCORDANCE WITH HIPAA POLICY. ADDITIONALLY, THERE WAS NO DEVICE INFORMATION DOCUMENTED IN THE ARTICLE, INCLUSIVE OF ANY DEVICES INVOLVED WITH THE RELATED PROCEDURE OR ANY ALLEGATIONS OF ANY DEVICE MALFUNCTIONS.

  Patient problems: Hematoma

  MAUDE report 18611085 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A PHYSICIAN REPORTED A PATIENT DEVELOPING A HEMATOMA POST-OPERATIVELY AFTER A MILD PROCEDURE WAS COMPLETED ON (B)(6) 2023. THE PATIENT INITIALLY COMPLAINED OF HIP PAIN AND WEAKNESS FOLLOWING THE MILD PROCEDURE, BUT THE PHYSICIAN HAD DIAGNOSED THE CONCERNS WITHIN NORMAL POST-OPERATIVE RANGE; HOWEVER, THE FOLLOWING DAY AFTER THE MILD PROCEDURE ON (B)(6) 2023, THE PATIENT EXHIBITED ISSUES STANDING AND WALKING, AFTER WHICH THE PATIENT WAS ADMITTED TO THE ER. THE LAST STATUS REPORTED WAS THAT THE PATIENT IS UNDER CARE AND WAS ASSESSED FOR POTENTIAL DECOMPRESSION; NO ADDITIONAL INFORMATION OF THE PATIENT'S CURRENT CONDITION HAS BEEN MADE AVAILABLE AT THIS TIME. THE PATIENT WAS REPORTED TO HAVE PRIOR HIP REPLACEMENT SURGERIES; HOWEVER, THERE WERE NO REPORTED CONCERNS WITH THE PATIENT'S ANATOMY OR ELIGIBILITY FOR THE MILD PROCEDURE PRIOR TO OPERATION.

  Patient problems: Hematoma

  MAUDE report 18504344 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VERTOS MEDICAL SALES REPRESENTATIVE RECEIVED INFORMATION REGARDING A PATIENT EXPERIENCING SEVERE PAIN POST-OPERATIVELY (REPORTED BACK, LEG, AND BUTT PAIN) FOLLOWING A MILD PROCEDURE COMPLETED THE SAME DAY (B)(6) 2023). THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6), WHERE A LAMINECTOMY WAS PERFORMED ON (B)(6) TO ADDRESS POST-PROCEDURAL COMPLICATIONS. THE PATIENT WAS LAST DISCHARGED ON (B)(6) 2023 AWAITING APPROVAL FOR PHYSICAL THERAPY; NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 18373867 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 11/13/2023, A COMPANY REPRESENTATIVE WAS INFORMED BY A PHYSICIAN THAT A MEDICAL LAWSUIT WAS FILED AGAINST THE PHYSICIAN ALLEGING PATIENT POST-PROCEDURAL COMPLICATIONS, INCLUSIVE OF DIFFICULTY WALKING, NUMBNESS, AND NERVE ISSUES, FOLLOWING A MILD PROCEDURE. THE PHYSICIAN REPORTED THAT POST-PROCEDURE INTERVENTIONAL SURGERY WAS PERFORMED TO ADDRESS ALLEGED POST-PROCEDURE COMPLICATIONS. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. THE INFORMATION OBTAINED ALLEGES INJURIES TO TWO PATIENTS AND THIS IS ONE OF TWO MDRS SUBMITTED.

  Patient problems: Movement Disorder; Neuropathy; Numbness

  MAUDE report 18322985 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 11/13/2023, A COMPANY REPRESENTATIVE WAS INFORMED BY A PHYSICIAN THAT A MEDICAL LAWSUIT WAS FILED AGAINST THE PHYSICIAN ALLEGING PATIENT POST-PROCEDURAL COMPLICATIONS, INCLUSIVE OF DIFFICULTY WALKING, NUMBNESS, AND NERVE ISSUES, FOLLOWING A MILD PROCEDURE. THE PHYSICIAN REPORTED THAT POST-PROCEDURE INTERVENTIONAL SURGERY WAS PERFORMED TO ADDRESS ALLEGED POST-PROCEDURE COMPLICATIONS. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Movement Disorder; Neuropathy; Numbness

  MAUDE report 18319032 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 A PATIENT WITH SEVERE SPINAL STENOSIS UNDERWENT A MULTI-LEVEL MILD PROCEDURE. A COMPANY REPRESENTATIVE, WHO WAS PRESENT DURING THE PROCEDURE, REPORTED THAT IT WAS UNEVENTFUL AND COMPLETED WITHOUT ANY ISSUES. ON (B)(6) 2023, THE TREATING PHYSICIAN REPORTED TO THE COMPANY REPRESENTATIVE THAT APPROXIMATELY ONE TO TWO DAYS POST OP, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CAUDA EQUINA SYNDROME. THE PATIENT UNDERWENT AN EMERGENCY PROCEDURE (EITHER A LAMINECTOMY OR A FUSION). THE EXACT DATE OF THE EMERGENCY PROCEDURE AND STATUS OF THE PATIENT IS UNKNOWN AT THE TIME OF THIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18156375 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 9/18/2023 VERTOS WAS MADE AWARE, VIA AN ONLINE ARTICLE, OF A LAWSUIT PERTAINING TO A MILD PROCEDURE. THE LAWSUIT ALLEGES THAT A MILD PROCEDURE PERFORMED ON (B)(6) 2022 RESULTED IN INJURY TO THE DURA AND/OR THE SPINAL NERVES DUE TO A MISIDENTIFICATION BY THE PHYSICIAN OF SCAR TISSUE AS LIGAMENTUM FLAVUM.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 17953540 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), A PATIENT HAD THE MILD PROCEDURE AT THE BILATERAL L1-L2 AND L2-L3 WITH NO EPIDUROGRAM. IT WAS REPORTED THAT TWO DAYS FOLLOWING THE PROCEDURE ON (B)(6) THE PATIENT HAD INCREASED PAIN GOING DOWN TO THE KNEES AFTER RESUMING THEIR BLOOD THINNER MEDICATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) WITH LEG WEAKNESS AND TROUBLE WALKING AND WAS DIAGNOSED WITH AN EPIDURAL HEMATOMA. HE WAS ADMITTED TO THE HOSPITAL, AND A SURGICAL HEMATOMA EVACUATION WAS PERFORMED AT T12-L1. THE PATIENT WAS DISCHARGED ON (B)(6) AND DID NOT GO TO THE MILD FOLLOW UP APPOINTMENT AND HAS NOT SPOKEN TO THE MILD PHYSICIAN OR HIS TEAM. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 17337389 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A PHYSICIAN REPORTED THAT A 180 POUND, 53 YEAR OLD MALE PATIENT WAS DIAGNOSED WITH AN EPIDURAL ABSCESS AND THEN HAD A SUBSEQUENT 2 LEVEL HEMILAMINECTOMY A WEEK AFTER THE MILD PROCEDURE. THE PROCEDURE WAS PERFORMED ON (B)(6) 2023 AND THE SITES TREATED WERE AT THE BILATERAL L3/4 & BILATERAL L4/5. AN EPIDURAL WAS PERFORMED AT THE L4/5 SITE USING LOSS OF RESISTANCE. THE PROCEDURE WAS REPORTEDLY PERFORMED WITHOUT ISSUE IN A USUAL MANNER. THE PHYSICIAN REPORTED THAT THE PATIENT WENT TO THE HOSPITAL, WAS DISCHARGED ON (B)(6) 2023, AND IS CURRENTLY DOING FINE. IT SHOULD BE NOTED THAT THIS PATIENT REPORTEDLY HAS HAD HEALING ISSUES POST-SURGICAL PROCEDURES AND TAKES PREDNISONE EVERY DAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16994550 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 A 220 POUND, 68 YEAR OLD FEMALE PATIENT UNDERWENT A BILATERAL L4-L5 MILD PROCEDURE. THE PROCEDURE WAS REPORTEDLY PERFORMED WITHOUT ISSUE, AND AN EPIDURAL WAS PERFORMED AS WELL USING LOSS OF RESISTANCE. ON (B)(6) 2023, THE PHYSICIAN REPORTED THE PATIENT WENT TO THE EMERGENCY ROOM IN THE EARLY HOURS OF 5/4 WITH A HEADACHE. AFTER SOME IMAGING, THE PATIENT WAS DIAGNOSED WITH PNEUMOCEPHALUS. PATIENT WAS DISCHARGED WITHIN 24 HOURS AND IS DOING FINE.

  Patient problems: Pneumocephalus

  MAUDE report 16994543 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 2/22/2023, A VERTOS REPRESENTATIVE WAS INFORMED BY A PHYSICIAN THAT A FEMALE PATIENT, WHO HAD THE MILD PROCEDURE ON (B)(6) 2023, WAS DIAGNOSED WITH A HEMATOMA. THE MILD PROCEDURE WAS UNDER IV MAC SEDATION AND NO EPIDUROGRAM WAS USED. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE IFU AND PHYSICIAN TRAINING. THE VERTOS REPRESENTATIVE WAS NOT PRESENT DURING THIS PROCEDURE. IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH A HEMATOMA THE FOLLOWING DAY. THE HEMATOMA WAS AT THE SAME LEVEL AS THE MILD PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DECOMPRESSION (LAMINECTOMY) WAS PERFORMED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED FOLLOWING THE LAMINECTOMY AND IS REPORTEDLY DOING WELL.

  Patient problems: Hematoma

  MAUDE report 16599734 ↗