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

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.

• Brand Name: PRECEPT TRAY
• Type of Device: STAINLESS STEEL K-WIRE
• Manufacturer (Section D): NUVASIVE
• MDR Report Key: 3775727
• MDR Text Key: 15109926
• Report Number: MW5035787
• Device Sequence Number: 1
• Product Code: HXI
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: PART # 8801000
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR