EIT PLIF Inserter PET30102Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04260397088050), received between Aug 12, 2021 and Apr 12, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K170503); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING INITIAL SURGERY SETUP, THE CONDUIT STRAIGHT IMPLANT HOLDER AND INNER THREADED DRIVER BECAME WELDED TOGETHER. SURGERY PROGRESSED WITHOUT THOSE INSTRUMENTS. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) INSERTER SH CONNECTION THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19099563 ↗
• MalfunctionMar 29, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 12-MARCH-2024, THE SURGEON HAD TROUBLE DETACHING THE INSERTER IN QUESTION FROM THE IMPLANT ONCE IT WAS POSITIONED IN SITU. EXCESSIVE FORCE WAS REQUIRED FOR THE DISENGAGEMENT OF THE IMPLANT HOLDER. THIS PROCESS CAUSED THE SPINDLE TIP TO FRACTURE, LEAVING IT EMBEDDED WITHIN THE IMPLANT. THE FRACTURE WAS FLUSH WITH THE IMPLANT AND COULD NOT BE REMOVED. THE BROKEN FRAGMENT WAS LEFT WITHIN THE IMPLANT INSIDE OF THE PATIENT BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES. THE GENERATED FRAGMENT WAS LEFT INSIDE OF THE IMPLANT, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN INSERTER S-HAMMER CONNECTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003223 ↗
• MalfunctionSep 14, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT THE ITEM PET30102 WITH LOT NUMBER E19DI0693 CONSISTS OF TWO PARTS BUT CANNOT BE PUT TOGETHER BECAUSE THE SCREW THREAD IS DEFECTIVE. THIS REPORT IS FOR ONE (1) INSERTER SH CONNECTION THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743639 ↗
• MalfunctionJun 15, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING SPINAL PROCEDURE BOTH POSTERIOR LUMBAR INTERBODY FUSION (PLIF) INSERTERS HAD INTERNAL THREAD DAMAGED AND THE ASSEMBLY WAS DONE WITH DIFFICULTY. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) INSERTER SH CONNECTION THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132616 ↗
• MalfunctionFeb 15, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, WHILE TIGHTENING THE CAGE INTO THE INSERTER, THE INTERNAL SHIFT BROKE AND THE SURGEON COULD NOT REMOVE THE CAGE. THE INSERTER WAS NOT INSIDE THE PATIENT DURING THIS TIME. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIFTEEN(15) MINUTES SURGICAL DELAY. SURGEON USED ANOTHER INSERTER TO COMPLETE THE PROCEDURE. NO FRAGMENTS WERE GENERATED AND NO MEDICAL INTERVENTION. THIS REPORT IS FOR ONE (1) INSERTER S-HAMMER CONNECTION. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382974 ↗
• MalfunctionFeb 9, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING IMPLANTATION OF CAGE, THE INNER SHAFT SEPARATED FROM THE T HANDLE INSERTER AND WOULDN¿T COME OFF THE CAGE WHILE IN THE PATIENT. THERE WAS 5 MINS OF SURGICAL DELAY. THERE WERE NO PATIENT OUTCOME. THIS COMPLAINT INVOLVES THREE DEVICES. THIS REPORT IS FOR ONE INSERTER SH CONNECTION. THIS IS REPORT 2 OF 3 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342868 ↗
• MalfunctionAug 25, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WANTED TO REPOSITION A SPACER IN THE PATIENT. UPON TRYING TO REATTACH THE HOLDER TO THE SPACER, THE INNER SHAFT WOULD NOT ENGAGE WITH THE SPACER. THE SURGEON WAS ABLE TO REPOSITION THE SPACER WITHOUT ENGAGING THE HOLDER WITHOUT CASE DELAY. UPON DISASSEMBLY OF THE HOLDER, THE SURGICAL TECH NOTICED THAT THE PROXIMAL PART OF THE INNER SHAFT HAD BECOME UNCONNECTED TO THE LONG THREADED SHAFT. THE HOLDER WAS MOVED IN ORDER TO FINISH THE SURGICAL STEP. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR AN INSERTER S-HAMMER CONNECTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293299 ↗
• MalfunctionAug 12, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TWO INSTRUMENTS BROKE AT THE WELDING SEAM INTRAOPERATIVELY. NO FRAGMENTS WERE GENERATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY AND WITH ANOTHER AVAILABLE INSTRUMENT. NO ADVERSE PATIENT HARM. THIS REPORT IS FOR ONE (1) INSERTER S-HAMMER CONNECTION THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312947 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170503. One submission often covers many models, so check the product and lot details in each record.

• Z-1323-2022 · May 20, 2022 · Open, Classified
  EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD
• Z-1324-2022 · May 20, 2022 · Open, Classified
  EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD