Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
General, Plastic Surgery · 21 CFR 878.3300
Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.
Recent MDR events
787 adverse event reports on file
- XENFORM BOVINE MATRIXDec 26, 2019InjuryUnkMW5091925
- ADVANTAGE FIT TRANSVAGINAL MID-URETHRAL SLINGJun 24, 2019MalfunctionBoston Scientific Corporation8727137
- XENFORM SOFT TISSUE REPAIR MATRIXOct 17, 2018InjuryBoston Scientific - Marlborough3005099803-2018-02617
- XENFORM SOFT TISSUE REPAIR MATRIXOct 11, 2018InjuryBoston Scientific - Marlborough3005099803-2018-02618
- XENFORM SOFT TISSUE REPAIR MATRIXOct 10, 2018InjuryBoston Scientific - Marlborough3005099803-2018-02616
- XENFORM SOFT TISSUE REPAIR MATRIXAug 15, 2018InjuryBoston Scientific - Marlborough3005099803-2018-02560
- XENFORM SOFT TISSUE REPAIR MATRIXMay 23, 2018InjuryBoston Scientific - Marlborough3005099803-2018-01543
- COLOPLASTApr 18, 2018MalfunctionColoplast A/s7439415
- XENFORM SOFT TISSUE REPAIR MATRIXApr 12, 2018InjuryTei Biosciences Incorporated3005099803-2018-00963
- XENFORM SOFT TISSUE REPAIR MATRIXFeb 20, 2018InjuryBoston Scientific - Marlborough3005099803-2018-00260
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
20 firms currently registered for this product code
Sterigenics Belgium Fleurus Sa
Fleurus Hainaut, BE
Synergy Health Ast, Llc
Saxonburg, PA, US
Sterilization Services Of Georgia, Inc.
ATLANTA, GA, US
Depuy Orthopaedics
BRIDGEWATER, MA, US
Tutogen Medical Gmbh
Neunkirchen am Brand Bavaria, DE
Bbf Sterilisationsservice Gmbh
Kernen Baden-Wurttemberg, DE
Rti Surgical, Inc. (dba Rti Biologics, Inc.)
ALACHUA, FL, US
Isomedix Operations Inc.
SPARTANBURG, SC, US
Dsm Biomedical, Inc.
EXTON, PA, US
Synergy Health Ast, Llc
SAN DIEGO, CA, US
Exel Inc. Dba Dhl Supply Chain (usa)
Mooresville, IN, US
Cook Incorporated
ELLETTSVILLE, IN, US
Synovis Life Technologies, Inc. (a Subsidiary Of Baxter International Inc.)
Saint Paul, MN, US
Cook Biotech, Inc.
West Lafayette, IN, US
Baxter Healthcare Corporation
ROUND LAKE, IL, US
510(k) clearances
2 clearances for this product code