Norian 07.704.110SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982131652), received between Feb 13, 2018 and Apr 19, 2023 — classified as 1 injury, 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 5 most recent of 5 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 10CC-S. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773283 ↗
• MalfunctionSep 14, 2020Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON AUGUST 18, 2020, THE SURGEON WANTED TO USE THE NORIAN FAST SET PUTTY FOR AN ANKLE CASE. THEY MIXED THE PUTTY ON THE BACK TABLE FOR NINETY (90) SECONDS. THE SURGEON PUT THE NORIAN IN THE DESIRED LOCATION, BUT AFTER SIX (6) MINUTES IT DID NOT CHANGE CONSISTENCY. THEY DRIPPED WARM SALINE ON THE NORIAN AND LET THE TOURNIQUET DOWN TO TRY AND CREATE A WARM AND WET ENVIRONMENT. AFTER THIRTY (30) MINUTES, THE NORIAN WAS STILL SOFT AND EVENTUALLY WASHED AWAY. THE TEAM SPENT TIME TROUBLESHOOTING TO TRY AND COME UP WITH WAYS TO ENHANCE THE ENVIRONMENT NEEDED FOR THE NORIAN PUTTY. THERE WAS A FORTY FIVE (45) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE FAST SET PUTTY 10 CC STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10530935 ↗
• MalfunctionAug 3, 2018Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT TWO (2) NORIAN DRILLABLE FAST SET PUTTY SOLIDIFIED TOO QUICKLY WHILE USING THE DELIVERY SYSTEM TO DELIVER THE BIOMATERIAL DURING A PROCEDURE ON (B)(6) 2018. THE SURGICAL TEAM WAS NOT ABLE TO GET IT OUT OF THE SYRINGE AS IT BECAME CLOGGED OR BLOCKED. THE ISSUE HAPPENED TWICE. THE PRODUCT WAS REPLACED WITH NORIAN DRILLABLE INJECT TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY RELATED TO THE INCIDENT REPORTED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: GRAFT DELIVERY DEVICE (PART 03.950.001S, LOT NUMBER UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE FAST SET PUTTY 10CC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7747169 ↗
• MalfunctionAug 3, 2018Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT TWO (2) NORIAN DRILLABLE FAST SET PUTTY SOLIDIFIED TOO QUICKLY WHILE USING THE DELIVERY SYSTEM TO DELIVER THE BIOMATERIAL DURING A PROCEDURE ON (B)(6) 2018. THE SURGICAL TEAM WAS NOT ABLE TO GET IT OUT OF THE SYRINGE AS IT BECAME CLOGGED OR BLOCKED. THE ISSUE HAPPENED TWICE. THE PRODUCT WAS REPLACED WITH NORIAN DRILLABLE INJECT TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY RELATED TO THE INCIDENT REPORTED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: GRAFT DELIVERY DEVICE (PART 03.950.001S, LOT NUMBER UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE FAST SET PUTTY 10CC. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7747151 ↗
• InjuryFeb 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT INITIAL SURGERY FOR OPEN REDUCTION INTERNAL FIXATION OF PROXIMAL HUMERUS FRACTURE. DURING THE SURGERY, NORIAN DRILLABLE FAST SET PUTTY 10CC-STERILE WAS PULLED OUT FROM PYXIS SYSTEM AND TEMPERATURE INDICATOR TURNED BLACK. THERE WAS FIVE MINUTES DELAY IN PROCEDURE AS SURGEON HAS TO USE NORIAN DRILLABLE FAST SET PUTTY 3 CC STERILE AND NORIAN DRILLABLE FAST SET PUTTY 5 CC STERILE TO COMPLETE THE PROCEDURE SUCCESSFULLY. SURGEON MENTIONED THAT HE NEEDED MORE NORIAN BUT COMPLETED SURGERY WITH 3CC AND 5CC NORIAN PUTTY. PATIENT WAS REPORTED AS STABLE POST OPERATIVELY. ADDITIONALLY, IT WAS NOTED THAT 3 CC, 5 CC, AND 10 CC NORIAN WERE ALL STORED IN SAME PYXIS SYSTEM AT SAME TEMPERATURE. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE FAST SET PUTTY 10CC STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7266631 ↗

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-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
• 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