Norian 07.704.105SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982131645), received between Apr 15, 2020 and Apr 19, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2023Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE NORIAN FAST SET PUTTY SOLIDIFIED TOO QUICK. IT COULD NOT INSERT THROUGH DELIVERY DEVICE. COMPETITOR'S EQUIPMENT WAS USED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE FAST SET PUTTY 5CC-SILE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773276 ↗
• MalfunctionMay 26, 2022Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT THE CONSISTENCY OF NORIAN DRILLABLE FAST SET PUTTY 5CC-STERILE WAS OFF AND WAS NOT MIXING CORRECTLY. IT WAS REPORTED THAT SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR THE FAST SET PUTTY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520019 ↗
• MalfunctionDec 10, 2020Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE NORIAN DRILLABLE INJECT 10CC FAILED TO MIX IN THE UNKNOWN ROTARY MIXER AND ALL THE SODIUM HYALURONATE WAS EJECTED FROM THE NORIAN POUCH DURING MIXING. WHEN THE SURGEON TRIED USING THE NORIAN DRILLABLE FAST SET PUTTY 5CC, IT HARDENED IMMEDIATELY WITHIN TEN (10) SECONDS OF GETTING IT MIXED. SO, THE SURGEON TRIED AGAIN OF 5CC OF UNKNOWN DRILLABLE INJECT AND IT WORKED WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF TWO (2) MINUTES. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN ROTARY MIXER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) NORIAN DRILLABLE FAST SET PUTTY 5CC-STERILE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10985168 ↗
• MalfunctionApr 15, 2020Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE TIBIA PLATEAU ON (B)(6) 2020, THE SURGEON FOUND OUT THAT AFTER MIXING THE STERILE NORIAN DRILLABLE FAST SET PUTTY THE CONSISTENCY WAS NOT ACCEPTABLE. THE NORIAN WAS ¿CHALKY¿ AND WOULD NOT ADVANCE THROUGH THE GRAFT DELIVERY DEVICE STERILE. THERE WAS A 5 MINUTES SURGICAL DELAY WHILE ANOTHER NORIAN WAS OPENED AND PREPARED WHICH MIXED UP WITH AN ACCEPTABLE CONSISTENCY AND WAS IMPLANTED IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS AND OUTCOME WERE GOOD WITH NO ADVERSE EFFECTS. CONCOMITANT DEVICES: GRAFT DELIVERY DEVICE STERILE (PART: 03.950.001S, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A NORIAN DRILLABLE FAST SET PUTTY 5CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962089 ↗

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-0618-2018 · Aug 10, 2017 · Terminated
  Norian Drillable Inject
• Z-0617-2018 · 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