N/A 5584111Recalls & reported problems
Medtronic Sofamor Danek, Inc. · DRIVER 5584111 CDHS 5.5/6.0 LOCK SLEEVE · Class 1
Quick summary
This Medtronic Sofamor Danek screwdriver is used in spinal surgery. Its 483 adverse event reports mostly describe the driver breaking, sometimes before surgery, with a spare driver used instead. Most reports note no symptoms in the patient. There are no deaths and 6 injuries, and reports fell from 157 in the prior 12 months to 79 in the last 12. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 492
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 492 adverse event reports that list this exact device (DI 00643169043640), received between Mar 20, 2017 and Sep 29, 2026 — classified as 6 injuries, 486 malfunctions.
The most frequently reported specific device problem is “Break” (425 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break425
- Material Deformation39
- Degraded10
- Material Twisted/Bent8
- Naturally Worn7
- Detachment of Device or Device Component6
- Mechanical Jam5
- Mechanics Altered5
Patient problems
- No Clinical Signs, Symptoms or Conditions444
- No Known Impact Or Consequence To Patient33
- Device Embedded In Tissue or Plaque18
- No Patient Involvement3
- Foreign Body In Patient1
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 492 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Information was received from multiple sources (Manufacturer Representative, User Facility) regarding a Patient device used for Spin al therapy. It was reported that the drivers broke. There was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927946 ↗MalfunctionSep 29, 2026Break
Information was received from multiple sources (Manufacturer Representative, User Facility) regarding a Patient device used for Spin al therapy. It was reported that the drivers broke. There was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927923 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840883 ↗MalfunctionSep 17, 2026Material Twisted/Bent
Information was received from user facility via a manufacturer representative regarding a Tap and Driver used for Spinal therapy. It was reported that the instruments were twisted. There was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50799925 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785063 ↗MalfunctionSep 15, 2026Break
Information was received from user facility via manufacturer representative regarding instruments used for Transforaminal Lumbar int erbody fusion procedures. It was reported that the instruments were broken. There was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767161 ↗MalfunctionSep 15, 2026Break
Information was received from user facility via manufacturer representative regarding instruments used for Transforaminal Lumbar int erbody fusion procedures. It was reported that the instruments were broken. There was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767154 ↗MalfunctionSep 15, 2026Break
Information was received from user facility via manufacturer representative regarding instruments used for Transforaminal Lumbar int erbody fusion procedures. It was reported that the instruments were broken. There was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50767116 ↗MalfunctionSep 10, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50708764 ↗MalfunctionSep 10, 2026Mechanics Altered
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50708041 ↗MalfunctionSep 9, 2026Degraded
Information was received from user facility via a manufacturer representative regarding a device used for L1-L2 Extreme Lateral Fusion, Hardware Removal L2-L3, T10-L4 Fusion with Hardware. It was reported that the scrub tech was having issues placing the Solera 5.5/6.0 screw tightly onto the end of the screwdriver. The tech removed the Solera pedicle screw and examined the tip of the screwdriver noticing severe wear and tear. There was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50686476 ↗MalfunctionSep 9, 2026Naturally Worn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50685123 ↗MalfunctionSep 9, 2026Naturally Worn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50685100 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151925 ↗MalfunctionAug 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515469 ↗MalfunctionAug 27, 2026Break
Information was received from user facility via manufacturer representative regarding a device being used for posterior lumbar fusion procedure. It was reported that before the surgery the tip of the screwdriver was broken off. Spare driver used for surgery. There was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50475092 ↗MalfunctionAug 6, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151599 ↗MalfunctionJul 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25885043 ↗MalfunctionJul 3, 2026Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DRIVER USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, DURING REGULAR CLEAN UP, THE TIP OF THE DRIVER WAS OBSERVED TO BE TWISTED AND APPEARED BURNT, AND THE DRIVER WAS OBSERVED TO HAVE BROKEN APART. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25702618 ↗MalfunctionJun 30, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT DRIVERS WERE BROKEN. THERE IS NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662717 ↗MalfunctionJun 30, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT DRIVERS WERE BROKEN. THERE IS NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662706 ↗MalfunctionJun 30, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBARINTE RBODY FUSION. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662238 ↗MalfunctionJun 30, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTE RBODY FUSION. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662233 ↗MalfunctionJun 30, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTE RBODY FUSION. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662221 ↗MalfunctionJun 26, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBARINTER BODY FUSION. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25633834 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.