Norian 07.704.010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982131621), received between Feb 7, 2018 and Sep 9, 2022 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE (B)(6) 2022, WHEN ATTEMPTED TO MIX NORIAN, THE CONNECTION BETWEEN THE SYRINGE THAT CONTAINS THE MIXING SOLUTION AND THE NORIAN ITSELF, WOULD NOT LOCK PROPERLY, CAUSING SOME OF THE SOLUTION TO LEAK OUT. WE ATTEMPTED TO COMPLETE THE MIXING BUT WERE UNSUCCESSFUL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 6MIN OF SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 10CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396677 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 PATIENT HAD REPAIR LEFT FEMUR MALUNION/NONUNION WITH AUTO GRAFT AND BONE GRAFTING LEFT FEMORAL HEAD. ON (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF HARDWARE HIP (LEFT) CONVERSION, PREVIOUS HIP SURGERY TO TOTAL HIP ARTHROPLASTY (LEFT). OPERATIVE FINDINGS WITH NON UNION FAILED TFN, LEFT SUPERIOR ACETABULAR DEFECT. ON (B)(6) 2020 PATIENT HAD UNDERGONE IRRIGATION AND DEBRIDEMENT HIP (LEFT) - PROSTHETIC HIP INFECTION. CONCOMITANT : TRIGEN INTERTAN 11.5MM X 18CM 125DEGREE (PART 71675202 LOT 19LMD7004,QUANTITY#1) INTERTAN LAG/COMPRESSION SCREW KIT 85MM / 80MM (PART 71677085 LOT 17BT8266, QUANTITY#1) TRIGEN (PART71645030 LOT 20320696,QUANTITY#1). THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 10CC-STERILE. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 15208387 ↗
• MalfunctionMay 5, 2022Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. THE LIQUID SOLUTION FROM THE NORIAN SYRINGE WOULD NOT INJECT INTO THE ROTARY POUCH INJECTION PORT, INSTEAD SPILLING OUT ALL OVER THE MIXER AND TABLE, EVEN THOUGH CARE WAS TAKEN TO ENSURE THE SYRINGE WAS SECURELY ATTACHED TO THE PORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3 MINUTES OF SURGICAL DELAY NOTED. NO FRAGMENTS WERE GENERATED. NO PATIENT OUTCOME WAS REPORTED. THIS REPORT INVOLVES ONE (1) NORIAN DRILLABLE INJECT 10CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286884 ↗
• MalfunctionMar 3, 2022Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A UNKNOWN PROCEDURE. IN A BILATERAL CALCANEUS FRACTURE CASE WE WENT TO PUT 10CC'S OF NORIAN IN ONE SIDE. WHILE MIXING THE DOC BROKE OFF THE ANTERIOR PROCESS OF THE CALCANEUS AND I WENT RUNNING FOR PLATES. IN THIS TIME THE NORIAN WAS OPENED WITHOUT HAVING BEEN ROLLED INTO THE SYRINGE AND WAS LEFT TO HARDEN IN THE PACKAGE. WE ULTIMATELY OPENED ANOTHER BOX AND USED THAT SUCCESSFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3 MINUTES OF SURGICAL DELAY NOTED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE NORIAN DRILLABLE INJECT 10CC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660630 ↗
• MalfunctionOct 15, 2021Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, WHEN THE NORIAN DRILLABLE INJECT WAS OPENED ONTO THE STERILE FIELD THE SURGICAL TECHNOLOGIST NOTICED THE PRODUCT WAS ALREADY HARDENED AND WAS UNABLE TO BE USED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 10CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12640215 ↗
• MalfunctionAug 12, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, THE SYRINGE WAS BEING INJECTED INTO THE POUCH BUT THE POUCH WOULD NOT ACCEPT AND IT STARTED TO COME OUT INTO THE SIDE. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316378 ↗
• MalfunctionMay 11, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHEN PREPARING THE SALINE, THE PRODUCT WOULD NOT GO INTO THE BAG. WHEN THE SURGEON INJECTED, THERE WAS AN UNFAMILIAR CLICKING SOUND. THE BAG WAS UNABLE TO BE USED. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 5CC-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11808585 ↗
• MalfunctionApr 5, 2021Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE SH SOLUTION THAT SUPPOSED TO INJECT INTO THE NORIAN BAG WOULD NOT INJECT. THE SOLUTION KEPT SHOOTING BACK OUT PREVENTING THE CALCIUM PHOSPHATE FROM BEING HYDRATED. I CHECKED THE SEAL AND RE-ATTACHED THE SYRINGE BUT STILL COULD NOT GET THE SOLUTION TO INJECT. A BACKUP SUPPLY WAS USED. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 10CC-STERILE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613351 ↗
• 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 10CC-STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599871 ↗
• MalfunctionMar 3, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 10 CC NORIAN DRILLABLE MIXED WITH THE SOLUTION WAS LEAKING AT THE ATTACHMENT SITE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) NORIAN DRILLABLE INJECT 10CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11403917 ↗
• MalfunctionDec 10, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  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 INJECT 10CC-STERILE. THIS REPORT IS 1 OF 2 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10985217 ↗
• MalfunctionSep 30, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, A MIXED 10CC NORIAN DRILLABLE INJECT HAD LEAKED WHEN PUSHED INTO CEMENT, THUS, WAS NOT USED FOR THE CASE. THE SURGEON USED A BACKUP OF 5CC. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO CONSEQUENCE TO PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN NORIAN DRILLABLE FAST SET PUTTY (PART# /LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 10CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9136165 ↗
• MalfunctionJul 10, 2018Chemical Problem; Chemical Problem

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A TIBIA FRACTURE ON (B)(6) 2018, A SYRINGE DID NOT LOCK PROPERLY TO THE POUCH OF A NORIAN DRILLABLE INJECT CAUSING THE SOLUTION TO LEAK. THE POUCH COULD NOT BE USED FOR THE PROCEDURE. THE SURGEON USED ANOTHER NORIAN DRILLABLE INJECT TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME REPORTED AS STABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7675578 ↗
• MalfunctionMay 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A FOOT SURGERY. DURING THE SURGERY, A 10CC POUCH OF NORIAN DRILLABLE INJECTABLE BONE VOID FILLER DID NOT MIX TO THE CORRECT CONSISTENCY. IT WAS TOO ¿WATERY¿ AND WAS UNABLE TO BE USED. THE 10CC NORIAN PRODUCT WAS DISCARDED. TWO 5CC POUCHES OF NORIAN DRILLABLE WERE OPENED AND MIXED TOGETHER AND WERE THE PROPER CONSISTENCY. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO SURGICAL DELAY. NO REPORTED HARM TO THE PATIENT. PATIENT OUTCOME WAS REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) NORIAN DRILLABLE INJECT 10CC-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7499478 ↗
• MalfunctionFeb 7, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A TARSOMETATARSAL (TMT) FOOT FUSION ON (B)(6) 2018, THE NURSE WAS ABOUT TO MIX THE NORIAN AND REMOVED THE CAP ON THE LIQUID PART OF THE SYRINGE WHEN THE LOCK CAME OFF AND PREVENTED THE LIQUID FROM MIXING INTO THE POWDER PACKET. ANOTHER NORIAN PACK WAS USED, BUT THE SURGEON HAD TO LOWER THE PATIENT¿S TOURNIQUET THEN RAISE IT BACK UP AND START OVER. THIS RESULTED IN A TEN (10) MINUTE SURGICAL DELAY. NO PATIENT HARM. PROCEDURE COMPLETE SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT 1 OF 1 (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7249692 ↗

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-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
• 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