Norian 07.704.003SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982131607), received between Jul 31, 2018 and Sep 1, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K073303, K102722); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2022Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2022, NORIAN DRILLABLE INJECT 3CC WAS TO BE USED DURING THE CASE, STEPS WERE FOLLOWED ACCORDINGLY PER TECHNIQUE GUIDE. AFTER THE MIXING CYCLE THE ROTARY POUCH WAS PLACED INTO THE TRANSFER ROLLER. THE ROLLER WAS TURNED COUNTERCLOCKWISE THE FULL LENGTH OF THE POUCH AND NO PASTE WAS DELIVERED INTO THE SYRINGE. THEREFORE, ANOTHER NORIAN DRILLABLE HAD TO BE USED TO COMPLETE THE CASE WITH NO ISSUES. THERE WAS 5 MINS OF SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR A NORIAN DRILLABLE INJECT 3CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15338449 ↗
• MalfunctionJan 13, 2022Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE NORIAN DRILLABLE INJECT 3CC WAS MIXED WITH ROTARY MIXER IN A CASE. ALL STEPS WERE FOLLOWED PROPERLY, TEMPERATURE INDICATOR WAS GOOD AS WELL AS EXPIRATION DATE; HOWEVER, NO INJECTABLE BONE VOID FILLER CAME OUT WHEN IT WAS PULLED. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) NORIAN DRILLABLE INJECT 3CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13254377 ↗
• MalfunctionSep 27, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2021, THE NORIAN DRILLABLE INJECT WOULD NOT FILL INTO THE SYRINGE AFTER MIXING, AND DISCARDED THE 3CC. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 3CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537550 ↗
• MalfunctionJun 30, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHILE PREPARING THE INJECTABLE, THE SYRINGE WAS NOT ATTACHED TO WHERE IT RECEIVED THE NORIAN INSIDE THE SYRINGE. IT WAS DETACHED, SO WHEN ROLLING IT THROUGH THE NORIAN MIXER , THE NORIAN WAS NOT GOING INTO THE SYRINGE, IT WAS SPREADING AT THE BACK. THERE IS A 5-MINUTE DELAY PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) NORIAN DRILLABLE INJECT 3CC-STERILE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092410 ↗
• MalfunctionMar 31, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE TWO EXTRA BOXES OF NORIAN DRILLABLE INJECT NEEDED TO BE OPENED BECAUSE THE NURSE FORGOT TO SQUEEGEE THE NORIAN INTO THE SYRINGE. TWO (2) NORIAN DRILLABLE INJECT CRACKED WHEN ATTACHING THE SYRINGE TO THE POUCH. IT WAS UNKNOWN WHEN THE ISSUE WHEN DISCOVERED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 3CC-STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599849 ↗
• MalfunctionOct 5, 2018Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE NORIAN DRILLABLE INJECT 3CC DID NOT MIX PROPERLY IN THE MIXER. MIXING ACCORDING TO INSTRUCTIONS WAS ATTEMPTED BUT WAS NOT SUCCESSFUL. ANOTHER NORIAN DRILLABLE INJECT 3CC WAS READILY AVAILABLE AND WAS MIXED SUCCESSFULLY. NO PATIENT OR SURGICAL INVOLVEMENT WAS REPORTED. CONCOMITANT DEVICE: MIXER (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 3CC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7940439 ↗
• MalfunctionJul 31, 2018Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF FEMORAL HEAD FRACTURE ON (B)(6) 2018, NOTHING CAME OUT INTO THE PATIENT FROM THE NORIAN DRILLABLE INJECT WHEN IT WAS ROLLED THROUGH THE ROLLER AFTER MIXING FOR 70 REVOLUTIONS. THE PRODUCT WAS WITHIN THE EXPIRATION DATE; THE TEMPERATURE INDICATOR WAS ADEQUATE; AND THE APPROPRIATE STEPS WERE FOLLOWED. ANOTHER NORIAN DRILLABLE INJECT WAS USED AND EVERYTHING WORKED APPROPRIATELY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A NORIAN DRILLABLE INJECT 3CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7736270 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073303, K102722. One submission often covers many models, so check the product and lot details in each record.

• Z-0617-2018 · Aug 10, 2017 · Terminated
  Norian Drillable Inject
• Z-0618-2018 · Aug 10, 2017 · Terminated
  Norian Drillable Inject
• Z-1942-2016 · May 11, 2016 · Terminated
  Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony str
• Z-1943-2016 · May 11, 2016 · Terminated
  Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony st
• Z-1944-2016 · May 11, 2016 · Terminated
  Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony s