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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. KYPHON KURVE KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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MEDTRONIC SOFAMOR DANEK, INC. KYPHON KURVE KIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number VPK1003
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/15/2021
Event Type  Injury  
Event Description
A 0.5 cm x 3 mm retained foreign body due to unexpected partial fracture of the distal aspect of the curved needle, which broke during kyphoplasty procedure.This is thought to be due to device malfunction and is unlikely to cause long-term problems given that its embedded/secured within the vertebral body on multiple projections.The rfo piece is in low risk area of vertebral body next to newly placed cement.The physician reported unusual bending with needle, did not apply more pressure than normal during advancement to fracture of vertebral body.While removing the needle, unusual torquing of the needle was noted.X-ray/fluoroscopy confirmed rfo.Fda safety report id # (b)(4).
 
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Brand Name
KYPHON KURVE KIT
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK, INC.
MDR Report Key11737430
MDR Text Key248152645
Report NumberMW5101023
Device Sequence Number1
Product Code LXH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVPK1003
Device Lot Number0221398951
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/27/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age93 YR
Patient Weight68
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