XENMATRIXRecalls & reported problems across all models

We found 20 models of XENMATRIX by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 106 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2017 and Sep 17, 2026 — classified as 4 deaths, 89 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (46 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported XENMATRIX problems

XENMATRIX models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

• XENMATRIX 1161935

  Mesh, surgical, collagen, plastic and reconstructive surgery
  20 reports
• XENMATRIX 1161015

  Mesh, surgical, collagen, diaphragmatic hernia
  13 reports
• XENMATRIX 1151935

  Collagen surgical mesh containing drugs
  10 reports
• XENMATRIX 1161928

  Mesh, surgical, collagen, diaphragmatic hernia
  9 reports
• XENMATRIX 1152025

  Collagen surgical mesh containing drugs
  1 death9 reports
• XENMATRIX 1151520

  Mesh, surgical
  8 reports
• XENMATRIX 1162025

  Mesh, surgical, collagen, plastic and reconstructive surgery
  7 reports
• XENMATRIX 1151015

  Collagen surgical mesh containing drugs
  6 reports
• XENMATRIX 1161520

  Mesh, surgical, collagen, plastic and reconstructive surgery
  5 reports
• XENMATRIX 1151928

  Mesh, surgical
  1 death5 reports
• XENMATRIX 1152020

  Collagen surgical mesh containing drugs
  4 reports
• XENMATRIX 1152540

  Collagen surgical mesh containing drugs
  2 reports
• XENMATRIX 1162020

  Mesh, surgical, collagen, plastic and reconstructive surgery
  1 death1 report
• XENMATRIX 1150606

  Mesh, surgical, collagen, plastic and reconstructive surgery
  1 report
• XENMATRIX 1150808

  Collagen surgical mesh containing drugs
  1 report
• XENMATRIX 1151010

  Mesh, surgical, collagen, plastic and reconstructive surgery
  1 report
• XENMATRIX 1151525

  Mesh, surgical
  1 death1 report
• XENMATRIX 1160610

  Mesh, surgical, collagen, diaphragmatic hernia
  1 report
• XENMATRIX 1153030

  Collagen surgical mesh containing drugs
  1 report
• XENMATRIX 1153045

  Mesh, surgical, collagen, plastic and reconstructive surgery
  1 report

Recent XENMATRIX adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathSep 17, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2005 - Patient was diagnosed with ventral hernia thereby underwent open repair with implant of Composix Kugel Patch (Device 1). Per operative notes, "An incision was made into the midline of the umbilicus. The hernia sac was dissected out. A large Composix Kugel Patch (Device 1) was placed into the preperitoneal cavity and secured it with sutures."(b)(6)2013 - Patient was diagnosed with adhesion, thereby underwent open repair with explant of Composix Kugel Patch (Device 1) and primary hernia repair. Per operative notes, "A midline incision was made into the abdomen. The old mesh (Device 1) was removed from abdominal wall. Multiple adhesions to the anterior abdominal wall were carefully lysed from both sides of the anterior abdominal wall. The defect was closed with sutures primarily."(b)(6)2014 - Patient was diagnosed with abdominal wall infection, ventral hernia, necrosis, abscess, purulent discharge thereby underwent open repair with implant of XenMatrix Graft (Device 2). Per operative notes, "An incision was made around the previous infected skin. There were necrotic tissues present into the abdominal cavity. The hernia sac was dissected out. Into

  Patient problems: Adhesion(s); Erosion; Fistula; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 50798277 ↗
• InjurySep 3, 2026Material Deformation

  Per information provided:On (b)(6) 2014 - Patient was diagnosed with ventral hernia thereby underwent open repair with the implant of Ventralex ST Mesh (Device 1). Per op notes, "A supraumbilical incision was made, a Ventralex ST Mesh (Device 1) was placed into the hernia defect using prolene sutures."On (b)(6) 2015 - Patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of synthetic mesh. Per op notes, "There was noted to be the old mesh at the level of the umbilicus and on the scar tissue, the scar was excised. Then a synthetic mesh was placed."On (b)(6) 2017 - Patient underwent excision of the abdominal wall scar.On (b)(6) 2017 - Patient was diagnosed with chronic abdominal wall infection and adhesions thereby underwent repair with removal of Ventralex ST mesh (Device 1) and synthetic mesh and implant of XenMatrix AB (Device 2). (Notes: No op notes were provided).On (b)(6) 2019 - Patient was diagnosed with recurrent incisional hernia thereby underwent repair removal of mesh (Device 2). Per op notes, "Included with hernia sac the old XenMatrix AB (Device 2) which had ballooned into the defect and was adherent to the hernia s

  Patient problems: Adhesion(s); Bacterial Infection; Hernia; Obstruction/Occlusion; Pain

  MAUDE report 50588119 ↗
• InjuryJul 27, 2026Patient-Device Incompatibility

  As per patient advocate:NI/NI/NI - The patient had a small bowel obstruction and underwent surgery which included creation of an ileostomy.On (b)(6) 2021- The patient underwent an Ileostomy Reversal and Abd Wall Reconstruction procedure with implant of a XenMatrix AB Graft (device #1). Post implant the patient experienced wound healing issues, seromas, infections and was treated with wound care and antibiotics.On (b)(6) 2022- The patient was diagnosed with a Ventral Hernia and underwent repair with implant of the Phasix Mesh (device #2).On (b)(6) 2022 - The patient was diagnosed with an Incarcerated Incisional Hernia and underwent repair with the implant of a Soft Mesh (device #3). As reported, the patient has not had any of the meshes removed. As reported, patient experienced multiple post operative complications including wound healing issues and chronic abdominal pain. Patient has had multiple epidural injections and had a pain stimulator with no relief. Reportedly, the patient is currently experiencing "inflammation in her gut and swelling in her left leg." Patient has seen at least 4 different gastroenterologists for her gastrointestinal issues, had been diagnosed with a pancr

  Patient problems: Abdominal Pain; Impaired Healing; Seroma; Unspecified Infection

  MAUDE report 50021379 ↗
• InjuryMay 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿THE OLD MESH WAS NOTED RETRACTED AND CURLED OVER WAS EXCISED. THE HERNIA SAC WAS NOTED AND EXCISED. A VENTRALEX MESH (DEVICE 1) WAS PLACED AND SUTURED.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT VENTRAL HERNIA AND OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿THE DEFECT FROM THE PREVIOUS MESH WAS NOTED AND THE CONTENTS OF HERNIA DEFECT WAS REDUCED AND EXCISED. THE OLD MESH (DEVICE 1) WAS WELL INCORPORATED AND DIFFICULT TO EXPLANT. THE HERNIA DEFECT WAS REPAIRED PRIMARILY WITH SUTURES.¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN AND INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, ¿MIDLINE INCISION WAS MADE. SIGNIFICANT ADHESIONS BETWEEN SMALL BOWEL AND THE OLD MESH WERE LYSED. THE RECURRENT HERNIA DEFECT WAS NOTED JUST LATERAL TO THE OLD MESH. SOME SEROUS FLUID COLLECTION ABOVE THE MESH WERE DRAINED. THE MESH (DEVICE 1) WAS EXCISED ENTIRELY. COMPONENT SEPARATION WAS PERFOR

  Patient problems: Hernia; Scar Tissue

  MAUDE report 25299807 ↗
• InjuryApr 2, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OPERATIVE NOTES, "AN UPPER ABDOMINAL VENTRAL HERNIA WAS NOTED. THE HERNIA SAC WAS REDUCED ALL THE WAY DOWN TO THE FASCIA AND REMOVED. A LARGE VENTRALEX ST MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND SUTURED IN UNDERLAY FASHION WITH SUTURES. THE FASCIAL DEFECT WAS CLOSED AND SECURED WITH SUTURES AND STAPLES." ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA WITH CHRONIC PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF XENMATRIX MESH (DEVICE 2) AND REMOVAL OF PRIOR MESH (DEVICE 1). PER OPERATIVE NOTES, THROUGH THE PRIOR INCISION, THE UPPER ABDOMINAL MIDLINE MESH (DEVICE 1) WAS SEEN FIRM AND EXCISED FROM THE SUBCUTANEOUS TISSUES AND OVERLYING SCAR TISSUES. MULTIPLE TITANIUM TACKS WERE ALSO REMOVED. THE RECURRENT FASCIAL DEFECT IN THE MIDLINE IN SUPRAUMBILICAL AREA WAS REMOVED AND FLAPS WERE RAISED. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES. A XENMATRIX MESH (DEVICE 2) WAS PLACED OVER THE FASCIA AND SECURED WITH SUTURES TO THE ANTERIOR ABDOMINAL WALL." ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WIT

  Patient problems: Abdominal Pain; Hernia; Scar Tissue

  MAUDE report 24764656 ↗
• InjuryFeb 27, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL INCISIONAL HERNIA WITH BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE THROUGH THE OLD SCAR. THERE WERE MULTIPLE HERNIA DEFECTS. HERNIA SAC WERE TAKEN DOWN. A SEPRAMESH IP (DEVICE 1) WAS PLACED INTO THE DEFECT AND SECURE IT WITH SUTURES.¿ ON (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INFECTED MESH, ABDOMINAL WALL ABSCESS, WITH FISTULA, THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF SEPRAMESH IP (DEVICE 1) AND LAPAROTOMY, PLACEMENT OF WOUND VAC. PER OPERATIVE NOTES, ¿A VERTICAL MIDLINE INCISION WAS MADE JUST BELOW THE UMBILICUS. THE HERNIA SAC WAS DISSECTED OUT. FISTULA WAS REMOVED FROM BELOW THE UMBILICUS. THERE WERE DENSE NUMBER OF ABSCESSES INTO THE ABDOMINAL WALL, WHICH WERE DRAINED. THE CHRONICALLY INFECTED PREVIOUSLY PLACED MESH WAS EXCISED PARTIALLY. THE WOUND WAS IRRIGATED AND VAC PLACEMENT WAS DONE.¿ ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCARCERATED VENTRAL/INCISIONAL HERNIA, ADHESIONS, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF XENMATRIX SURGICAL GRAFT (DEVICE 2) AND EXPLANT OF SEPRAME

  Patient problems: Abscess; Purulent Discharge

  MAUDE report 24466403 ↗
• InjuryFeb 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE MIDLINE, THREE DISCRETE DEFECTS IN A ROW WERE NOTED AND CONNECTED. THE FASCIA WAS CLOSED WITH SUTURES AND BARD FLAT MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND SECURED WITH SUTURES.¿ (B)(6) 2016: PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF PRIOR MESH (DEVICE 1) AND IMPLANT OF XENMATRIX AB MESH (DEVICE 2) AND PHASIX MESH (DEVICE 3). PER OPERATIVE NOTES, ¿IN THE MIDLINE, THE PRIOR MESH (DEVICE 1) WAS HARDENED AND FILL THE VENTRAL HERNIA. ADHESIONS WERE LYSED AND HERNIA ONE ABOVE AND BELOW THE BELLYBUTTON WERE REDUCED. THE PRIOR MESH (DEVICE 1) WAS PARTIALLY REMOVED AND ABSCESS WAS DRAINED. THE XENMATRIX AB MESH (DEVICE 2) WAS PLACED OVER THE FASCIA AND REAPPROXIMATED WITH SUTURES. THE FASCIA WAS REINFORCED AND PHASIX MESH (DEVICE 3) WAS PLACED AND SECURED WITH SUTURES AND OPTIFIX TACKERS.¿ (B)(6) 2016: PATIENT WAS DIAGNOSED WITH INFECTED WOUND THEREBY UNDERWENT INCISION AND DRAINAGE OF INFECTED WOUND AND SEROMA. PE

  Patient problems: Necrosis; Post Operative Wound Infection; Seroma

  MAUDE report 24454606 ↗
• InjuryFeb 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE 1). PER OP NOTES, ¿THE LARGE CHRONIC HERNIA SAC WAS EXCISED. THERE WAS A SEPARATE HERNIA NEAR THE UMBILICUS FROM CHRONIC INCISION. THE SEPRAMESH IP (DEVICE 1) WAS PLACED TO COVER ALL THE DEFECTS AND FASCIA WAS CLOSED PRIMARILY USING SUTURES. THEN THE MESH WAS TACKED ALL AROUND THE EDGE AND HERNIA ITSELF USING PROTACKS.¿ (B)(6) 2017 ¿ PATIENT HAD PAIN AND WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, ABSCESS, INFECTED MESH THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF XENMATRIX AB (DEVICE 2). PER OP NOTES, ¿THE ABSCESS CAVITY FULL OF GROSS PUS WAS SUCTIONED OUT. IN CAVITY, SUTURES AND MESH WAS NOTED. ADHESION WAS TAKEN DOWN. THE MESH (DEVICE 1) WAS REMOVED AND FASCIAL DEFECT WAS ENCOUNTERED. A PIECE OF XENMATRIX AB (DEVICE 2) WAS PLACED AS UNDERLAY TO REPAIR THE DEFECT AND ANCHORED TO FASCIA WITH SUTURE. THE MESH WAS TACKED CIRCUMFERENTIALLY TO ANTERIOR ABDOMINAL WALL.¿ 07-NOV-2017 ¿ PATIENT HAD ABDOMINAL PAIN AND WAS DIAGNOSED WITH NECROTIC OPEN ABDOMINAL WOUND THEREBY UN

  Patient problems: Abdominal Pain; Necrosis; Wound Dehiscence

  MAUDE report 24321655 ↗
• InjuryJan 8, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2000- PATIENT WAS DIAGNOSED WITH GIANT VENTRAL INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA WAS IDENTIFIED IN RIGHT UPPER QUADRANT. A BARD FLAT MESH WAS ATTACHED TO FASCIA OF LEFT UPPER QUADRANT AND RIGHT UPPER QUADRANT AND SUTURED¿. (B)(6) 2002- PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿THE BARD FLAT MESH (DEVICE 1) WAS IDENTIFIED TO BE LOOSEN FROM THE LATERAL ABDOMINAL WALL. A HERNIA WITH OMENTUM WAS IDENTIFIED IN THE RIGHT LATERAL ABDOMINAL REGION. THE BARD FLAT MESH (DEVICE 1) WAS SUTURED TO THE LATERAL ABDOMINAL WALL¿. (NOTE: THERE IS NO INDICATION IN THE MEDICAL RECORDS PROVIDED THAT THE PATIENT WAS IMPLANTED WITH A BARD FLAT MESH (DEVICE 2) DURING THIS REPAIR) (B)(6) 2019- PATIENT WAS DIAGNOSED WITH ENTEROCUTANEOUS FISTULA, THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿THE SMALL INTESTINE WAS ADHERENT TO PREVIOUSLY PLACED MESH OF THE ABDOMINAL WALL, WHICH RESULTED IN THE ENTEROCUTANEOUS FISTULA. SEVERE ADHESIONS WERE ALSO NOTED WITH THE BARD FLAT MESH AND WAS LYSED.

  Patient problems: Abscess; Pain; Purulent Discharge

  MAUDE report 24002476 ↗
• InjuryJan 3, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA X 2 THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE 1). PER OP NOTES, ¿TWO SEPARATE HERNIAL DEFECTS BOTH WITH INCARCERATED OMENTUM AND ONE WITH SOME SMALL BOWEL LOOPS WERE IDENTIFIED. THE CONTENTS OF THE HERNIA WAS TAKEN DOWN. A PIECE OF COMPOSIX E/X MESH (DEVICE 1) WAS PLACED AND FIXED WITH THE ABSORBATACK.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA X 2 THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF XENMATRIX AB MESH (DEVICE 2). PER OP NOTES, ¿HERNIA DEFECT WAS IDENTIFIED AND THE SAC WAS FORMED AT THE EDGE OF PREVIOUS MESH (DEVICE 1) REPAIR. REMOVED 2 STAPLES FROM PREVIOUS REPAIR. COMPLEX ABDOMINAL WALL AND THICK PREPERITONEAL FAT LAYER WAS NOTED AND BOTH DEFECTS WERE SUTURED. A PIECE OF XENMATRIX AB MESH (DEVICE 2) WAS PLACED OVERLYING BOTH DEFECTS AND SECURED WITH SUTURES.¿ ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH SEROMA OF ABDOMINAL WALL THEREBY UNDERWENT DRAINAGE. PER OP NOTES ¿UPPER LEVEL OF SEROMA WAS IDENTIFIED AND OLD METABOLIZED HEMATOMA WAS SUCTIONED OUT. A JACKSON-PART DRAIN WAS PLACED IN THE SEROMA CAVITY AND SUT

  Patient problems: Hematoma; Seroma

  MAUDE report 23952898 ↗
• InjuryJan 2, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A VERTICAL INCISION WAS MADE OVER THE SUPRAUMBILICAL MIDLINE OVER THE HERNIA MASS. THE HERNIA SAC WAS REMOVED. A VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURE IT WITH SUTURES.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH WOUND INFECTION, SCAR TISSUE THEREBY UNDERWENT OPEN REPAIR WITH EXPLORATION AND DEBRIDEMENT OF WOUND. PER OPERATIVE NOTES, ¿A VERTICAL INCISION WAS MADE IN THE UMBILICUS. PREVIOUSLY PLACED MESH WAS WELL INCORPORATED. SCAR TISSUE WAS REMOVED. WOUND WAS IRRIGATED. VAC PLACEMENT WAS DONE FOR WOUND.¿ (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA; CHRONIC WOUND INFECTION, SCAR TISSUE THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX MESH (DEVICE 1) AND IMPLANT OF XENMATRIX MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE PRIOR HERNIA SITE WAS IDENTIFIED IN THE PERIUMBILICAL AREA. THE OLD SCAR WAS IDENTIFIED AND REMOVED ENTIRELY. THE HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED VENTRALEX MESH (DEVICE 1) WAS REMOVED. CHRONIC DRAINAGE WAS DONE FROM THE WOUND. V

  Patient problems: Necrosis; Seroma; Wound Infection

  MAUDE report 23941375 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2006 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). (NOTE: THERE IS NO OPERATIVE NOTES FOR THIS PROCEDURE PROVIDED IN MEDICAL RECORD) ON (B)(6) 2006 ¿ PER HOSPITAL COURSE, PATIENT HAD STATUS POST REPAIR OF AN INCARCERATED UMBILICAL HERNIA, WHICH HAS BEEN CAUSING BOWEL OBSTRUCTION. ON (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH FOREIGN BODY, UMBILICAL HERNIA WOUND THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿PATIENT NOTED TO HAVE SOME DRAINAGE COMING FROM THE PERIUMBILICAL SITE. PATIENT WAS ALSO NOTED TO HAVE A CIRCULAR MESH IN THE WOUND. THIS WAS DISSECTED FREE FROM ALL SURROUNDING TISSUES AND WHEN MOBILIZING ON THE LEFT SIDE THERE WAS NOTED TO BE A SMALL BOWEL LOOP WHICH WAS FIRMLY ADHERENT TO THE MESH AND ON FREEING THIS, A SMALL ENTEROTOMY. THIS WAS CLOSED USING SUTURES. THE VENTRALEX MESH (DEVICE 1) WAS COMPLETELY REMOVED.¿ ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF XENMATRIX SURGICAL GRAFT (DEVICE 2). PER OPERATIVE NOTES, ¿THE HERNIA DEFECT AND THE SAC WAS D

  Patient problems: Adhesion(s); Fistula

  MAUDE report 23787640 ↗
• InjuryOct 31, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A VENTRIO MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SUTURED.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF VENTRIO MESH (DEVICE 1) AND AN IMPLANT OF XENMATRIX SURGICAL GRAFT (DEVICE 2). PER OPERATIVE NOTES, ¿THE VENTRIO MESH (DEVICE 1) WAS SOMEWHAT BALLED UP AND WAS COMPLETELY REMOVED. A XENMATRIX SURGICAL GRAFT (DEVICE 2) WAS PLACED INTO THE ABDOMEN AND SUTURED.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT HERNIA WITH MULTIPLE MESHES THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF XENMATRIX SURGICAL GRAFT (DEVICE 2) AND AN IMPLANT OF VENTRALIGHT ST MESH (DEVICE 3) AND PHASIX MESH (DEVICE 4) AND LYSIS OF ADHESIONS. (NOTE: THE OP NOTES PROVIDED FOR THIS PROCEDURE IS INCOMPLETE)

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23438152 ↗
• InjuryAug 27, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OP NOTES, "A VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE ABDOMINAL WALL USING PROLENE SUTURES." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF XENMATRIX (DEVICE 2). PER OP NOTES, "A MIDLINE INCISION WAS MADE. ADHESIOLYSIS WAS PERFORMED, THE OLD MESH (DEVICE 1) WAS EXCISED. A XENMATRIX (DEVICE 2) WAS PLACED INTO RECTRO RECTUS SPACE USING PROLENE SUTURES." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 3). PER OP NOTES, "THE PREVIOUSLY PLACED BIOLOGIC MESH (DEVICE 2) HAD TORN IN HALF AND RETRACTED. DENSE ADHESIONS TO THE MESH WERE CLEARED. A VENTRALIGHT ST MESH (DEVICE 3) WAS PLACED ABOVE THE LEVEL OF THE BIOLOGIC MESH (DEVICE 2) AND BELOW HE PERITONEUM." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH USING EC

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22901737 ↗
• InjuryAug 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC TO OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE LARGE HERNIA DEFECT WAS NOTED. A LARGE PIECE OF VENTRIO MESH (DEVICE #1) WAS PLACED AND TACKED CIRCUMFERENTIALLY USING SUTURES.¿ (B)(6) 2013 ¿ PATIENT HAD ABDOMINAL PAIN AND WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE LYSIS OF ADHESION. PER OPERATIVE NOTES, ¿A DENSE AMOUNT OF ADHESION TO ANTERIOR ABDOMINAL WALL AND MESH (DEVICE #1) WERE TAKEN DOWN. A PORTION OF THE SMALL BOWEL HAD AREA OF STRICTURED WAS RESECTED AND ANASTOMOSED SIDE TO SIDE FASHION.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH DEEP SURGICAL SITE INFECTION THEREBY UNDERWENT DEBRIDEMENT OF WOUND. PER OPERATIVE NOTES, ¿SUTURES WERE REMOVED TO REVEAL A LARGE AMOUNT OF PURULENT MATERIAL. SOME OF NECROTIC SUBCUTANEOUS TISSUE WERE DEBRIDED.¿ (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS THEREBY UNDERWENT INCISION AND DRAINAGE OF ABSCESS. PER OPERATIVE NOTES, ¿THE ABSCESS POCKET WAS IDENTIFIED, AND LARGE AMOUNT OF PURULENT DRAINAGE WAS EXPRESSED

  Patient problems: Seroma

  MAUDE report 22748983 ↗

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