Reflex Hybrid 48511906BRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07613327276855), received between Mar 4, 2016 and Mar 14, 2022 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Break” (23 reports).

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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2022Fracture; Fracture

  A COMPANY REPRESENTATIVE REPORTED THAT THE TIP OF A REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR FRACTURED WHEN REMOVING A SCREW FROM THE PLATE AND THE REFLEX HYBRID PLATE HOLDER IS,"COMING APART." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT CAPTURES THE REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13763305 ↗
• MalfunctionDec 23, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR BROKE OFF INTRA-OPERATIVELY. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13079127 ↗
• MalfunctionNov 16, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE REFLEX HYBRID REVISION DRIVER DRAW ROD WAS OBSERVED TO BE BROKEN UPON INSPECTION. THERE WAS NO PROCEDURE ASSOCIATED WITH THIS EVENT. NO SURGICAL DELAY NOR ADVERSE CONSEQUENCES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819951 ↗
• MalfunctionApr 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SCHEDULED REVISION OF A CERVICAL PLATE, THE TIP OF THE INNER SHAFT OF A REFLEX HYBRID DRIVER BROKE OFF. THE FRACTURED PIECE WAS REMOVED FROM THE SURGICAL SITE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 1 MINUTE SURGICAL DELAY BY USING AN ALTERNATIVELY AVAILABLE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686261 ↗
• MalfunctionNov 6, 2018Fracture; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE REVISION DRIVER BROKE OFF INTRA-OP. ALL BROKEN FRAGMENTS WERE RETRIEVED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING BACK UP DEVICE. NO CONSEQUENCES TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8043247 ↗
• MalfunctionOct 30, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT A TIP OF THE INNER SHAFT REVISION DRIVER BROKE DURING A REVISION SURGERY. THE DEVICE WAS BEING USED BY A REPRESENTATIVE FROM A DIFFERENT COMPANY. A PLATE WAS SUCCESSFULLY REMOVED WITH A BACKUP DEVICE. THERE IS NO REPORT OF ADVERSE CONSEQUENCES OR SURGICAL DELAY IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8019043 ↗
• MalfunctionOct 29, 2018Fracture; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE INNER SHAFT OF THE SCREW EXTRACTOR BROKE OFF. NO CONSEQUENCE TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8016507 ↗
• MalfunctionOct 29, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TIP OF THE INNER SHAFT OF THE SCREW EXTRACTOR BROKE OFF. NO CONSEQUENCE TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8016506 ↗
• MalfunctionOct 29, 2018Fracture; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE INNER SHAFT OF THE SCREW EXTRACTOR BROKE OFF. NO CONSEQUENCES TO THE PATIENT IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8016486 ↗
• MalfunctionOct 29, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT THE TIP OF THE INNER SHAFT OF THE SCREW EXTRACTOR BROKE OFF. NO CONSEQUENCES TO THE PATIENT IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8016473 ↗
• MalfunctionAug 27, 2018Break; Fracture; Difficult to Remove; Fracture

  SURGEON BROKE THE DRAW ROD ON 2 REMOVAL INSTRUMENTS UPON TRYING TO REMOVE THE SCREWS FROM THE 2 LEVEL PLATE. SURGEON ENDED UP NOT BEING ABLE TO REMOVE THE SCREWS AND PLATE AND WENT ON WITH THE SURGERY. THIS CAUSED A DELAY OF 5 MINUTES.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7817285 ↗
• MalfunctionAug 27, 2018Break; Fracture; Difficult to Remove; Fracture

  SURGEON BROKE THE DRAW ROD ON 2 REMOVAL INSTRUMENTS UPON TRYING TO REMOVE THE SCREWS FROM THE 2 LEVEL PLATE. SURGEON ENDED UP NOT BEING ABLE TO REMOVE THE SCREWS AND PLATE AND WENT ON WITH THE SURGERY. THIS CAUSED A DELAY OF 5 MINUTES.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7817261 ↗
• MalfunctionMay 31, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT DURING INITIAL IMPLANTATION, THE SURGEON WANTED TO REPOSITION A SCREW. THE SURGEON ATTACHED THE SCREWDRIVER ON THE SCREW, STARTED TO ROTATE AND THE TIP OF THE INNER SHEATH BROKE. THE TIP REMAINS IN THE HEAD OF THE SCREW. THERE ARE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7558676 ↗
• MalfunctionFeb 6, 2018Break; Fracture; Fracture

  IT AS REPORTED THAT A TIP OF THE REMOVAL DRIVER INNER SHAFT BROKE OFF DURING FINAL SCREW REMOVAL. THE BROKEN TIP WAS RETRIEVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT IMPACT OR DELAY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7246016 ↗
• MalfunctionNov 17, 2017Break; Entrapment of Device; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; ACDF REMOVAL OF PLATE. UPDATE 11/15/2017: DURING A ROUTINE PLATE REMOVAL. PATIENT FUSED WELL BUT WAS ADDRESSING THE ADJACENT LEVEL FOR AN ACDF. BONE HAD IMBEDDED IN SCREW HEAD. TIP OF INSTRUMENT BROKE. ALL BROKEN FRAGMENTS RETRIEVED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7040355 ↗
• MalfunctionAug 21, 2017Break; Material Integrity Problem; Break; Material Integrity Problem; Unintended Movement

  IT WAS REPORTED THAT; THE DRAW ROD OF THE REMOVAL TOOL WAS SEATED INTO THE SCREW BUT WAS ROCKED BACK AND FORTH AND THE TIP WAS REMOVED FROM IT.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6809356 ↗
• MalfunctionJul 31, 2017Material Integrity Problem; Break; Material Integrity Problem; Mechanical Jam

  IT IS REPORTED THAT WHILE INSERTING THE LAST SCREW ON A PLATE THE SURGEON NOTICED THE SCREW WASN'T GOING BELOW THE RING. THE SURGEON TRIED REDIRECTING THE SCREW TWO TIMES AND THE MEDIAL PART OF THE RING IN THE HOLE WAS STILL NOT ABLE TO BE SEEN. THE SURGEON WAS UNSURE IF THE RING WAS PRESENT AND THEREFORE DECIDED TO REMOVE THE PLATE. THE SURGEON SAW THAT THERE WAS A RING BUT THE RING WAS WEDGED/JAMMED AND THERE WAS NO GIVE. NEW PLATE SAME SIZE WAS IMPLANTED. NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. ADDITIONALLY, WHILE REMOVING THE SCREW TO REMOVE THE PLATE, THE TIP OF THE REVISION DRIVER BROKE. ALL BROKEN FRAGMENTS WERE RETRIEVED AND THE TIP OF THE DRIVER REMAINS IN THE SCREW. THE DRIVER HAS BEEN USED SEVERAL TIMES.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6755579 ↗
• MalfunctionApr 11, 2017Break; Detachment Of Device Component; Fracture; Fracture

  IT WAS REPORTED THAT THE TIP IF THE INNER SHAFT REVISION DRIP BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6482714 ↗
• MalfunctionMar 13, 2017Break; Detachment Of Device Component; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT; THE TIP OF THE DRAW ROD BROKE OFF IN THE SCREW HEAD AND WAS UNABLE TO REMOVE FROM SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6399550 ↗
• MalfunctionFeb 13, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT "ADJACENT LEVEL SURGERY WAS BEING PERFORMED (ANTERIOR CERVICAL), WE WE'RE REMOVING OLD PLATE TO FIT NEW PLATE AT NEW DISEASED LEVEL. WHILE USING THE REMOVAL DRIVER, THE INNER-ROD TIP BROKE OFF IN THE SCREW HEAD. CAUSED A 45 SECOND DELAY WHILE THE SCREW WAS REMOVED THE REST OF THE WAY WITH A REGULAR DRIVER. IT DID NOT AFFECT PATIENT OR OUTCOME, AND THE BROKEN PIECE WAS NOT RETRIEVED DUE TO HARDWARE BEING RETURNED TO PATIENT POST CASE. IT'S BEEN USED MAYBE 100 TIMES AND HAS BEEN USED SUCCESSFULLY IN THE PAST."

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6326958 ↗
• MalfunctionFeb 6, 2017Break; Detachment Of Device Component; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DOCTOR HAD AN ACDF REVISION AND WAS REMOVING THE PLATE (NOTHING WRONG WITH THE PLATE), AND THE THREADED PORTION OF THE DRAW ROD (48511906B)BROKE OFF INTO THE SCREWHEAD DURING REMOVAL. HE WAS ABLE TO GET THE SCREWS AND PLATE OUT SUCCESSFULLY AFTER THAT BUT THE TIP OF THE INNER SHAFT BROKE OFF.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6305632 ↗
• MalfunctionFeb 3, 2017Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT; TRYING TO REMOVE PREVIOUSLY IMPLANTED PLATE FROM PATIENT, WHEN THE INNER FIXATION ROD BROKE WHILE BEING UTILIZED WITH REMOVAL DRIVER. THERE WAS A DELAY WHILE THEY EXTRACTED BROKEN TIP FROM SCREW HEAD, BUT ULTIMATELY DID NOT IMPACT THE PATIENT AND USED A SECONDARY INNER ROOD TO FINISH REMOVAL. CASE WAS FINISHED SUCCESSFULLY, AND THE INSTRUMENT HAS BEEN USED HUNDREDS OF TIMES. UPDATE 1/16/2017: THE PLATE WAS BEING TO REMOVED TO CORRECT AN ADJACENT LEVEL DEGENERATION THAT REQUIRED A NEW PLATE DUE TO THE PREVIOUS FUSION ALREADY FUSED. NOT A REVISION SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6301347 ↗
• MalfunctionJan 9, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE INNER DRAW ROD ON THE REVISION SCREW DRIVER BROWN DURING A 2 LEVEL HWR WITH ADJACENT LVL ACDF. THE DISTAL TIP OF THE DRIVER BROKE OFF. OTHER SCREWDRIVER WAS USED AND EVERYTHING CAME OUT FINE. NO ADDITIONAL TIME WAS ADDED TO THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6234198 ↗
• MalfunctionDec 27, 2016Fracture; Material Integrity Problem; Break; Detachment Of Device Component; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; TIP OF SCREWDRIVER BROKE OFF OF THE TIP OF THE DRAW ROD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6206925 ↗
• MalfunctionDec 5, 2016Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT THE TIP OF DRAW ROD BROKE OFF IN SCREW WHILE ATTEMPTING TO REMOVE. INSTRUMENT HAS BEEN USED FOR 50+ SURGERY'S, AND OVER TIGHTENED BY SURGEON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6146210 ↗