SpaceOAR System SO-2101Recalls & reported problems

Summary

The FDA's MAUDE database contains 353 adverse event reports that list this exact device (DI 00864661000102), received between Dec 16, 2016 and Mar 19, 2026 — classified as 1 death, 147 injuries, 205 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (246 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Feb 24, 2022Open, Classified

   Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.

   Z-1002-2022 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 353 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Malposition of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR WAS USED DURING A PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT LOOKED LIKE THE GEL MOVED TOWARDS THE APEX, MOST LIKELY DEPOSITED ANTERIOR TO DENOVILLIER'S FASCIA, WHICH ALLOWED IT TO SPREAD OUT BILATERALLY. ALSO, THE LOWER NEEDLE TRACT MIGHT HAD LET IT SPREAD TO THE PENILE BULB. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED, AND IT FOUND THAT THE HYDROGEL HAD SPREAD NEAR THE PROSTATE CAPSULE TO THE LEFT AND THE RIGHT POSTERIORLY. THEN, IT GATHERS NEAR THE APEX, AND A SMALL AMOUNT GOES INFERIORLY NEAR THE PENILE BULB. ALSO, IT APPEARS TO BE HYDROGEL NEAR BOTH NEUROVASCULAR BUNDLES. DUE TO THESE FINDINGS, THE PHYSICIAN WILL PLACE A RECTAL BALLOON ON THE PATIENT, BECAUSE; THERE IS BASICALLY NO PROTECTION FROM THE HYDROGEL. THE PATIENT IS EXPECTED TO START HIS RADIATION TREATMENT SOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645971 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A SPACEOAR PLACEMENT PROCEDURE IN 2019 DEVELOPED XANTHOGRANULOMATOUS INFLAMMATION IN THE IMPLANTED AREA IN (B)(6) 2025. IT WAS REPORTED THAT "THERAPY IS NO LONGER ON-GOING" WHICH MAY INDICATE THAT THE PATIENT'S RADIATION TREATMENT WAS INTERRUPTED DUE TO THE EVENT OR HAD BEEN COMPLETED AT THE TIME THE EVENT DEVELOPED. THE PATIENT NEEDED TO BE HOSPITALIZED AND UNDERWENT AN UNSPECIFIED INTERVENTION. THE CURRENT PATIENT STATE OF HEALTH WAS UNKNOWN.

  Patient problems: Fibrosis; Inflammation

  MAUDE report 24645124 ↗
• MalfunctionFeb 27, 2026Malposition of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR WAS USED DURING A PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING A MAGNETIC RESONANCE IMAGING (MRI), IT WAS NOTICED THAT THERE WAS A RECTAL WALL INVASION AT THE MIDGLAND AREA. THERE WERE NO PATIENT COMPLICATIONS, THE PATIENT IS REPORTED TO BE ASYMPTOMATIC. THERE WAS A DELAY ON THE PATIENT'S RADIATION TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24473411 ↗
• MalfunctionDec 16, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A SPACEOAR PLACEMENT PROCEDURE HAD A MAGNETIC RESONANCE IMAGING (MRI) SCAN SHOWING THE HYDROGEL LOCATED WITHIN THE RECTAL WALL AT THE APEX, WHICH WAS CLASSIFIED AS GRADE 3. THERE WERE NO PATIENT COMPLICATIONS AS RESULTED OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821397 ↗
• MalfunctionDec 16, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT SPACEOAR PLACEMENT PROCEDURE, HAD A DEEP INFILTRATION OF THE HYDROGEL, THIS WAS RATE AS GRADE 3 RECTAL WALL INFILTRATION (RWI) RIGHT UP AT THE BASE. THE PATIENT WAS ALREADY TREATED WITH STEREOTACTIC BODY RADIATION TREATMENT (SBRT) AND DID FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821391 ↗
• MalfunctionNov 12, 2025Use of Device Problem; Obstruction of Flow; Use of Device Problem; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR WAS USED DURING A PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025, UNDER MONITORED ANESTHESIA CARE (MAC). DURING THE INJECTION, AFTER INJECTING A FEW CCS OF THE HYDROGEL, THE APPLIER PAUSED, AND WHEN ATTEMPTED TO CONTINUE, THE Y-ADAPTOR AND INJECTION NEEDLE WERE ALREADY CLOGGED. NO PATIENT COMPLICATIONS WERE REPORTED, BUT THE PROCEDURE WAS CANCELLED POST-SEDATION. THE PATIENT WILL CONTINUE TO RECEIVE PLANNED RADIATION TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538468 ↗
• InjuryAug 25, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPACEOAR PLACEMENT PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2025, AND SUBSEQUENT RADIATION THERAPY WAS PERFORMED. IN (B)(6) 2025 THE PATIENT EXPERIENCED RECTAL BLEEDING AND WAS SEEN BY A GASTROENTEROLOGIST (GI). THERE APPEARED TO BE AN AIR POCKET IN THE PATIENT'S RECTUM. THE PHYSICIAN WAS UNSURE IF A RECTAL WALL INJECTION OF THE HYDROGEL OCCURRED. THE PATIENT IS SCHEDULED FOR A SECOND OPINION AND WAS PRESCRIBED ANTIBIOTICS. THE PATIENT IS CURRENTLY NOT HAVING ANY RECTAL BLEEDING OR PAIN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22891413 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A SPACEOAR IMPLANT UNDER MAC (MONITORED ANESTHESIA CARE) SEDATION. FOLLOWING THE PROCEDURE, THE PHYSICIAN SUSPECTED THE PATIENT WAS EXPERIENCING AN ALLERGIC REACTION. HOWEVER, THE PHYSICIAN WAS UNABLE TO PROVIDE FURTHER DETAILS AS THE PATIENT WAS BEING TRANSFERRED TO THE EMERGENCY ROOM. DESPITE BSC'S EFFORTS, NO FURTHER PATIENT HEALTH INFORMATION, UNDERLYING HEALTH CONCERNS, DETAILS ON THE EVENT AND THE PATIENT'S COURSE AFTER THE EVENT, OR DETAILS REGARDING POST PROCEDURE MONITORING AND OBSERVATION HAVE BEEN RECEIVED TO DATE. IF BSC RECEIVES ADDITIONAL PERTINENT INFORMATION, IT WILL BE PROVIDED TO THE FDA IN A SUPPLEMENTAL MEDICAL DEVICE REPORT.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 22812593 ↗
• MalfunctionJul 18, 2025Positioning Problem; Migration; Positioning Problem; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPACEOAR PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN, WITH A RESIDENT PRESENT, PLACED A SPACEOAR CLASSIC DEVICE. NOTABLY, THE SPHINCTER WAS OBSERVED TO BE UNUSUALLY HIGH, PROMPTING THE PHYSICIAN TO ADJUST THE NEEDLE PLACEMENT TO TARGET THE BASE AND SEMINAL VESICLES. HOWEVER, A SUBSEQUENT COMPUTERIZED TOMOGRAPHY (CT) SIMULATION REVEALED THAT SOME OF THE HYDROGEL HAD INADVERTENTLY BEEN INJECTED INTO THE PROSTATE. POST-OPERATIVELY, THE PATIENT EXPERIENCED URINARY DIFFICULTIES, LEADING TO URINARY RETENTION, NECESSITATING THE INSERTION OF A CATHETER. A POST-VOID RESIDUAL (PVR) TEST SHOWED A SIGNIFICANT VOLUME OF 250CC. A RECENT MAGNETIC RESONANCE IMAGING (MRI) REVEALED THAT APPROXIMATELY 99% OF THE GEL HAS MIGRATED TO THE BULBAR URETHRA, BELOW THE LEVEL OF THE GU DIAPHRAGM, WITH VERY LITTLE REMAINING IN THE PROSTATE AREA.

  Patient problems: Urinary Retention

  MAUDE report 22543548 ↗
• MalfunctionJul 7, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A SPACEOAR WAS IMPLANTED IN A PATIENT. THE DEVICE WAS SUCCESSFULLY IMPLANTED AT THE BASE AND MIDGLAND OF THE PROSTATE, BUT AN ISSUE AROSE AT THE APEX. UPON EXAMINATION, IT WAS FOUND THAT SOME HYDROGEL FROM THE DEVICE WAS LOCATED UNDER THE RECTAL WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22422680 ↗
• MalfunctionJul 2, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A SPACEOAR WAS IMPLANTED, AND AN IMAGE REVIEW REVEALED THAT THE HYDROGEL IS CORRECTLY PLACED AT THE BASE, BUT AT THE MIDGLAND, THERE IS A BREACH OF THE RECTAL WALL, AND THEN AT THE APEX, THERE WAS A FULL BREACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391365 ↗
• MalfunctionApr 23, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT UPON SPACEOAR AND TRANSPERINEALLY FIDUCIAL MARKERS PLACEMENT, A RECTAL WALL INFILTRATION (RWI) OCCURRED. THE RADIOLOGIST ASSESSED THE PLACEMENT AS A GRADE 3 RWI. A REVIEW OF THE MAGNETIC RESONANCE IMAGING (MRI) RESULTS SHOWED FULL THICKNESS RECTAL WALL INFILTRATION FROM 9 TO 12 O'CLOCK, WITH THE HYDROGEL PUSHING CLOSE TO THE MUCOSA. THE HYDROGEL WAS OBSERVED TO BE IN THE RIGHT AT THE BASE AND THEN GET UNDER THE RECTAL WALL NEAR THE MIDGLAND AND APEX. IT WAS SUSPECTED THAT DURING HYDRODISSECTION THE NEEDLE MUST HAVE NICKED THE RECTAL HUMP UPON INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895767 ↗
• MalfunctionDec 2, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE SPACEOAR WAS INSERTED AND FOUND TO BE POSITIONED IN THE OUTER LAYER OF THE PATIENT'S RECTAL WALL. DESPITE THIS UNEXPECTED PLACEMENT, THE PATIENT HAS NOT REPORTED ANY ADVERSE EFFECTS OR ISSUES. BOSTON SCIENTIFIC CORPORATION HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20826026 ↗
• MalfunctionOct 8, 2024Positioning Problem; Positioning Problem

  AFTER THE HYDROGEL PLACEMENT, THERE WAS A SUSPICION OF RECTAL WALL INFILTRATION. DURING SIMULATION, THE HYDROGEL WAS NOT VISIBLE, PROMPTING A MAGNETIC RESONANCE IMAGING (MRI) SCAN. THE MRI REVEALED POTENTIAL INFILTRATION OF THE ANTERIOR RECTAL WALL WITH HYDROGEL AT THE MIDGLAND. ADDITIONALLY, THE PATIENT HAS DIVERTICULITIS IN THE SIGMOID COLON. UPON FURTHER EVALUATION OF THE MRI, ONE SLICE SHOWED APPROXIMATELY 1 CM OF HYDROGEL BENEATH THE RECTAL WALL, WITH A REASONABLE AMOUNT OF MUSCULARIS BEHIND IT. ANOTHER SLICE INDICATED ABOUT 2-3 MM OF HYDROGEL CLOSE TO THE MUCOSA, WHICH WAS THE ONLY SLICE WITH HYDROGEL NEAR THE MUCOSA. THE REMAINING HYDROGEL APPEARED TO BE PRIMARILY WITHIN THE PROSTATE CAPSULE ON THE RIGHT POSTEROLATERAL SIDE AND IN THE VENOUS PLEXUS EXTENDING UP TO THE RIGHT INTERNAL ILIAC.

  Patient problems: Embolism/Embolus

  MAUDE report 20398662 ↗
• InjurySep 20, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT AFTER THE SPACEOAR PLACEMENT, THE PATIENT HAD BEEN HAVING DISCOMFORT DURING HIS POST-PROCEDURAL VOIDING TRIAL. THE PATIENT WAS EXAMINED, AND IT WAS FOUND FRAGMENTS OF SPACEOAR HYDROGEL AT THE TIP OF THE PATIENT'S PENIS. THE GEL WAS PULLED OUT OF THE PATIENT'S URETHRA AND A CYSTOSCOPY WAS PERFORMED; IT WAS EXTRACTED WHAT APPEARED TO BE FRAGMENTS OF HYDROGEL WITHIN THE PATIENT'S BLADDER. THE ONLY ABNORMALITY REPORTED BY THE PHYSICIAN ON THE CYSTOSCOPY OTHER THAN THE GEL FRAGMENTS REMOVED FROM THE BLADDER WAS A RED SPOT ON THE BACK OF THE PATIENT'S BLADDER CLOSE TO A URETERAL ORIFICE. THE PHYSICIAN REPORTED NO INJURIES OR PUNCTURE SITES WERE SEEN ON OR WITHIN THE URETHRA. NO ISSUES WERE OBSERVED DURING THE HYDRODISECTION AND THE PLACEMENT PROCEDURE, THE PLACEMENT WAS FAR AWAY FROM THE SEMINAL VESICLES AND THE PATIENT'S BLADDER. THE PLACEMENT WAS CONFIRMED TO BE IN THE CORRECT PLACE VIA DIGITAL RECTAL EXAMINATION. THE PHYSICIAN DECIDED TO TREAT THE PATIENT WITH ANTIBIOTICS TO AVOID INFECTION. THE PATIENT WAS SENT HOME WITHOUT SYMPTOMS OF PAIN; HOWEVER, URINARY RETENTION WAS REPORTED.

  Patient problems: Discomfort; Urinary Retention

  MAUDE report 20274268 ↗
• MalfunctionAug 21, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT AFTER THE HYDROGEL PLACEMENT PROCEDURE, MAGNETIC RESONANCE IMAGING (MRI) SHOWED ALMOST ALL THE HYDROGEL WAS IN THE RIGHT PLACE, HOWEVER NEAR THE MID GLAND APPROXIMATELY 2-3 CC OF THE HYDROGEL INFILTRATED IN THE RECTAL WALL. THEREFORE, THE PHYSICIAN DECIDED TO DELAY THE PATIENT'S RADIATION TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20014583 ↗
• MalfunctionAug 21, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A SPACEOAR VUE DEVICE AND TRANSPERINEALLY FIDUCIAL MARKERS WERE IMPLANTED UNDER GENERAL ANESTHESIA. DURING THE PROCEDURE, A POTENTIAL HYDROGEL MISPLACEMENT OCCURRED. DURING INJECTION WHEN THE PHYSICIAN WITHDREW THE NEEDLE, THERE WAS A CHANCE THAT A SMALL VOLUME OF HYDROGEL WAS DEPOSITED DISTALLY TO THE APEX OR IN THE RECTAL HUMP. IT WAS NOTED THAT DURING THE HYDRODISSECTION PHASE, THE APEX DID NOT OPEN AS EXPECTED, SUGGESTING THE PRESENCE OF ADHESIONS OBSTRUCTING THE SPACE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010466 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THE PATIENT WAS GIVEN VALIUM AND PERCOCET PROPHYLACTICALLY. AFTER THE PROCEDURE, THE PATIENT LOOKED PALE AND TRIED TO STAND, HOWEVER HE FELL AND LOST CONSCIOUSNESS. THE PATIENT ALSO VOMITED, AND THE PHYSICIAN DECIDED TO CALL AN AMBULANCE. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER), WHERE HIS BLOOD PRESSURE WENT BACK UP AFTER FIVE HOURS. THE PHYSICIAN BELIEVED THAT THE PATIENT EXPERIENCED A VASOVAGAL RESPONSE. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: Fall; Loss of consciousness; Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 19589735 ↗
• InjuryJun 18, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT AFTER THE SPACEOAR HYDROGEL PLACEMENT PROCEDURE THE PATIENT HAD AN INFILTRATION OF THE HYDROGEL IN THE RECTUM. THE PATIENT ALSO HAD PARTIAL FISTULA AND RECEIVED AN OSTOMY BAG TO TAKE PRESSURE OFF OF THE RECTUM. THE PATIENT'S RADIATION TREATMENT WAS DELAYED DUE TO THIS EVENT. THE PATIENT CONDITION WAS REPORTED AS FULLY RECOVERED.

  Patient problems: Fistula

  MAUDE report 19564147 ↗
• MalfunctionJun 14, 2024Material Integrity Problem; Positioning Problem; Material Integrity Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE SPACEOAR HYDROGEL PLACEMENT PROCEDURE SIX MONTHS AGO. THE DEVICE IS STILL PRESENTS IN THE PATIENT; ADDITIONALLY, AN INFILTRATION OF THE HYDROGEL INTO THE RECTAL WALL OCCURRED. THE PATIENT'S CURRENT CONDITION REMAINS UNKNOWN AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543108 ↗
• InjuryJun 11, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT AFTER THE HYDROGEL PLACEMENT PROCEDURE, IT WAS NOTED THE HYDROGEL WAS INJECTED IN THE WRONG LOCATION, THEREFORE THE PATIENT WAS UNABLE TO STARTED WITH HIS RADIATION TREATMENT, IT WAS ALSO REPORTED THAT THE PATIENT IS CURRENTLY ON HYPERBARIC THERAPY. THE ISSUE WAS REPORTED AS ONGOING, THE PATIENT CURRENT CONDITION WAS UNKNOWN AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 19512939 ↗
• MalfunctionMay 9, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT WHO RECEIVED A HYDROGEL SPACER AND FIDUCIAL MARKERS UNDER GENERAL ANESTHESIA, EXPERIENCED HYDROGEL A MISPLACEMENT. THE HYDROGEL WAS IDENTIFIED TO BE IN THE POSTERIOR PROSTATE AND RECTUM, EXTENDING TO THE ANTERIOR WALL OF THE LOWER RECTUM. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC, AND THE EXPECTATION IS TO BE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282878 ↗
• MalfunctionMay 9, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR DEVICE WAS IMPLANTED DURING A SPACEOAR PLACEMENT PROCEDURE ON (B)(6) 2024. THE IMAGES REVEALED THAT SOME OF THE HYDROGEL WAS PLACED INTO THE RECTAL WALL, IN THE SEROSA AND PENETRATED THE MUSCULARIS. ON THE SAGITTAL VIEW THE HYDROGEL SEEMED TO BE NEAR TO THE APEX OF THE PROSTATE. DUE TO THE EVENT THE STEREOTACTIC BODY RADIATION TREATMENT (SBRT) WAS DELAYED, TO AVOID THE RISK OF ULCERATION. THE PATIENT WAS REPORT ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281405 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPACEOAR DEVICE WAS IMPLANTED DURING A SPACEOAR PLACEMENT PROCEDURE ON LATE JANUARY. THE PROCEDURE WAS PERFORMED WITH LOCAL ANESTHESIA. LATER, AROUND THREE WEEKS LATER, THE PATIENT STARTED RADIATION TREATMENT, AT THE SAME TIME THE PATIENT STARTED WITH URINARY PROBLEMS, A FOLEY CATHETER WAS IMPLANTED, THIS EVENT DEVELOPED INTO PAIN IN THE PELVIS AND WITH URINATION. THE RADIATION TREATMENT FINISHED ON AT THE END OF MARCH. THE PATIENT'S PAIN WAS WORSE AND WAS SPREADING TO HIS ABDOMEN, THEREFORE, THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN THAT SHOWED A FLUID COLLECTION WHERE THE HYDROGEL WAS SUPPOSED TO BE, AROUND 5CM AROUND. DUE TO THIS EVENT, THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS FOR TWO WEEKS. THE PHYSICIAN KEPT HIS WATCH ON THIS PATIENT AND WILL CONSIDERER TO DRAIN THE FLUID. THE PATIENT CURRENT CONDITION IS UNKNOWN AT THE TIME OF THIS REPORT.

  Patient problems: Abscess; Pain; Urinary Retention

  MAUDE report 19237940 ↗
• MalfunctionApr 12, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A HYDROGEL SPACER WAS IMPLANTED ON (B)(6) 2023. AFTER A ROUTINE FOLLOW-UP, A COMPUTERIZED AXIAL TOMOGRAPHY SCAN AND MAGNETIC RESONANCE IMAGING REVEALED THAT THE HYDROGEL WAS STILL IN THE PATIENT'S ANATOMY AFTER 10 MONTHS FROM THE PLACEMENT. THE PATIENT EXPERIENCED A CHANGE IN HIS BOWEL HABITS, REPORTED AS MAINLY FLAT-SHAPED WASTE. IN ADDITION, THE PATIENT ALSO EXPERIENCED DIARRHEA. THE PATIENT WAS REFERRED TO A GASTROENTEROLOGIST, WHO DID NOT RECOMMEND A COLONOSCOPY.

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

  MAUDE report 19102300 ↗