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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE PRECEPT TRAY; STAINLESS STEEL K-WIRE

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NUVASIVE PRECEPT TRAY; STAINLESS STEEL K-WIRE Back to Search Results
Model Number PART # 8801000
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/03/2014
Event Type  Injury  
Event Description
Lumbar 5- sacral 1 alif performed.Pt flipped prone to proceed with l5-s1 percutaneous pedicle screw fixation.K-wire placed into vertebral body sacral one, screw placed over the k-wire and into the vertebral body.Xray taken, k-wire noted to be bent at a right angle, slap hammer for k-wire utilized to remove wire.Tip of k-wire broke off into vertebra body sacral one upon removing the k-wire.Dr (b)(6) aware and upon his clinical decision has decided to leave it in the s1 vertebral body.
 
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Brand Name
PRECEPT TRAY
Type of Device
STAINLESS STEEL K-WIRE
Manufacturer (Section D)
NUVASIVE
MDR Report Key3775727
MDR Text Key15109926
Report NumberMW5035787
Device Sequence Number1
Product Code HXI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPART # 8801000
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/22/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age40 YR
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