VERTECEM II 03.702.215SRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10705034721699), received between Oct 12, 2018 and Jan 8, 2024 — classified as 11 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (9 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, 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: INSTABILITY, COMPLICATION TIME/INTERVENTION, REPEAT SURGERY. THIS REPORT INVOLVES ONE VERTECEM V+ SYRINGE KIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 18467584 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: DURAL LESION, FRACTURE VERTEBRAL STRUCTURES, ADJACENT SEGMENT PATHOLOGY, OTHER COMPLICATION TIME/INTERVENTION. INTRAOPERATIVE, REPEAT SURGERY. THIS REPORT INVOLVES ONE VERTECEM V+ SYRINGE KIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Insufficient Information; Osteolysis; Unspecified Tissue Injury

  MAUDE report 18467211 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: HARDWARE REMOVAL, IMPLANT MALPOSITION, INSTABILITY, NON-UNION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE DBX AND VERTECEM V+ CEMENT PRODUCTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information; Joint Laxity; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18466530 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: NEUROCOMPRESSION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS REPORT IS FOR A VERTECEM V+ SYRINGE KIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 18466136 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: IMPLANT MALPOSITION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE VERTECEM V+ (OUS ONLY), VERTECEM V+ CEMENT (VERTECEM V+ SYRINGE KIT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18465446 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: INSTABILITY, NON-UNION. COMPLICATION TIME/INTERVENTION. REPEAT SURGERY. THIS IS FOR VERTECEM V+ CEMENT AND VERTECEM V+ (OUS ONLY) PRODUCTS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Joint Laxity; Nonunion/Delayed-union Bone Fracture

  MAUDE report 18465044 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: DURAL LESION, NEUROCOMPRESSION. COMPLICATION TIME/INTERVENTION. INTRAOPERATIVE, REPEAT SURGERY. THIS IS FOR DEPUY SYNTHES SPINE DBX AND VERTECEM V+ CEMENT PRODUCTS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nerve Damage; Unspecified Tissue Injury

  MAUDE report 18464830 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: NEUROCOMPRESSION COMPLICATION TIME/INTERVENTION REPEAT SURGERY THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 18455397 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA): SPINE TANGO SOA REPORT - TLIF. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED: DURAL LESION, ADJACENT SEGMENT PATHOLOGY, NEUROCOMPRESSION, COMPLICATION TIME/INTERVENTION, INTRAOPERATIVE, REPEAT SURGERY. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Nerve Damage; Osteolysis; Unspecified Tissue Injury

  MAUDE report 18455170 ↗
• InjuryAug 3, 2022Break; Failure to Eject; Break; Failure to Eject

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY (L2) FOR TREATING COMPRESSION FRACTURE DUE TO OSTEOPOROSIS ON (B)(6) 2022. ONCE THEY STARTED MIXING UP CEMENT MATERIALS, THE HANDLE BECAME IMMOVABLE. THEY CONTINUED THE PROCEDURE WITH REPLACEMENTS. WHEN THEY ATTACHED A SYRINGE TO A CEMENT NEEDLE, THE SYRINGE HAPPENED TO BE CONNECTED AT A SLANTED ANGLE. WHEN THE SYRINGE WAS DETACHED FOR A RETRIAL, THE TIP BROKE OFF. THE REST OF THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1)VERTECEM V+ SYRINGE KIT THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15159160 ↗
• InjuryJul 22, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SPINAL FUSION FOR TREATING LUMBAR COMPRESSION FRACTURE ON (B)(6) 2022. AFTER THEY FILLED UP THE 4TH SYRINGE WITH CEMENT, THEY TRIED TO RELEASE THE SYRINGE FROM THE STOP COCK. THEN, THE TIP OF THE SYRINGE BROKE OFF. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT WHICH RESULTED IN 10 MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VERTECEM V+ SYRINGE KIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15087236 ↗
• MalfunctionOct 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS:IT WAS REPORTED THAT ON (B)(6), 2021, DURING A PERCUTANEOUS VERTEBROPLASTY (TH9) PROCEDURE FOR TREATING CENTRUM FRACTURE, THE SYRINGE COULD NOT BE ATTACHED TO THE CEMENT NEEDLE ACCURATELY. THE CEMENT LEAKED FROM THE IMPROPERLY CONNECTED AREA ON THE SYRINGE. IT WAS FOUND THAT THE TIP OF THE SYRINGE HAD BROKEN OFF AND STAYED INSIDE THE CEMENT NEEDLE. THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS WITHOUT SURGICAL DELAY.THIS REPORT IS FOR ONE (1) VERTECEM V+ SYRINGE KIT THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12684197 ↗
• MalfunctionOct 12, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY (L1) FOR TREATING COMPRESSION FRACTURE DUE TO OSTEOPOROSIS ON (B)(6), 2021. AFTER THE CEMENT WAS MIXED UP, THE STAFF CHECKED THE MIXED CEMENT TO CONFIRM IT WAS READY FOR USE. THE AIR IN THE CEMENT MIXING DEVICE WAS SQUEEZED OUT. NEXT, THE 2-WAY CONNECTOR WAS MOUNTED HOWEVER, THE CEMENT DID NOT COME OUT. IT WAS CONFIRMED THAT THE CEMENT ON THE MIXER SIDE FLOWED BUT NOTHING CHANGED ON THE SYRINGE SIDE OF THE CONNECTOR. THE BLACK RUBBER RING LOCATED INSIDE THE CEMENT MIXERS CAP CAME OFF DURING TROUBLESHOOTING. THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS AND REQUIRED LESS THAN 30-MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VERTECEM V+ SYRINGE KIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616042 ↗
• MalfunctionJul 15, 2021Failure to Eject; Failure to Eject

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE SYRINGES WERE NOT ABLE TO BE FILLED WITH THE CEMENT. THE PROCEDURE WAS COMPLETED WITH REPLACEMENTS. THEY WERE NOT ABLE TO IDENTIFY POSSIBLE CAUSE(S) SUCH AS HARDENED CEMENT OR DEVICE DEFECTIVENESS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VERTECEM V+ SYRINGE KIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174470 ↗
• MalfunctionNov 2, 2020Packaging Problem; Packaging Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING A VERTEBROPLASTY PROCEDURE, WHEN THE SURGICAL CEMENT WAS LOADED INTO THE 1CC SYRINGES IT PROPELLED FROM THE PLUNGER. THIS PREVENTED LOADING THE CEMENT FOR INJECTION. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ALTERNATIVE 2CC SYRINGES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN CEMENT (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR ONE (1) VERTECEM V+ SYRINGE KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10771382 ↗
• MalfunctionMar 23, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT WHEN SYRINGES OF THE VERTECEM SYRINGE KIT WERE FILLED WITH VERTECEM V+ CEMENT, THE PUNCHEON BACKED OUT OF THE BARREL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY OR CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR A VERTECEM SYRINGE KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9864805 ↗
• MalfunctionMar 12, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, THE TIP OF THE BLUE VERTECEM SYRINGE (1ML) BROKE WHILE REMOVING FROM CEMENT RESERVOIR (VERCETEM V+CEMENT KIT). OTHER SYRINGES HAD NO ISSUES AND COULD BE USED TO FINISH THE PROCEDURE. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAYED AND PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: VERCETEM V+CEMENT KIT (PART# 07.702.016S, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8414868 ↗
• MalfunctionMar 4, 2019Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS FURTHER REPORTED THE SURGEON USED THE OTHER SYRINGES ON THE SET TO SUCCESSFULLY COMPLETE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8387978 ↗
• MalfunctionMar 1, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, TWO (2) VERTECEM SYRINGE KITS WERE BENT AND BROKEN AFTER REMOVING FROM THE VERTECEM CEMENT KIT RESERVOIR. IT WAS NOT POSSIBLE ANYMORE TO ATTACH THE SYRINGES TO THE STANDARD LUER NEEDLE SINCE THE TIP OF THE SYRINGE SCREW GOT BENT AND BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING OTHER SYRINGES THAT WERE STILL GOOD. NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN VERTECEM CEMENT KIT (PART # 07.702.016S, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) VERTECEM V+ SYRINGE KIT . THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8381868 ↗
• MalfunctionMar 1, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, TWO (2) VERTECEM SYRINGE KITS WERE BENT AND BROKEN AFTER REMOVING FROM THE VERTECEM CEMENT KIT RESERVOIR. IT WAS NOT POSSIBLE ANYMORE TO ATTACH THE SYRINGES TO THE STANDARD LUER NEEDLE SINCE THE TIP OF THE SYRINGE SCREW GOT BENT AND BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING OTHER SYRINGES THAT WERE STILL GOOD. NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN VERTECEM CEMENT KIT (PART # 07.702.016S, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) VERTECEM V+ SYRINGE KIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8381867 ↗
• MalfunctionOct 12, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP (¿NOSE¿) OF THE SYRINGES BROKE OFF. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) VERTECEM V+ SYRINGE KIT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7962605 ↗
• MalfunctionOct 12, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP (¿NOSE¿) OF THE SYRINGES BROKE OFF. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) VERTECEM V+ SYRINGE KIT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7962593 ↗