MAUDE Adverse Event Report: NUVASIVE, INC.; PITUITARY RONGEUR, 2MM

Model Number 6940429

Device Problem Fracture (1260)

Patient Problems Atrial Fibrillation (1729); Hemorrhage/Bleeding (1888)

Event Date 01/29/2015

Event Type  Injury  

Event Description

During surgery on (b)(6) 2015 at the t11-12 spine level, the rongeur reportedly broke and a fragment lodged near the dural space.Retrieval required partial corpectomy.The pt was reported to have lost 2.2 liters of blood, necessitating transfusion and extended hospitalization.

Manufacturer Narrative

(b)(4).Review of the device history record notes no material non-conformances or mfg errors that may have caused or contributed to this mode of failure.Root cause of the reported event is undetermined at this time.It is unclear if the pt's medical history was a contributing factor to the reported blood loss.

• Type of Device: PITUITARY RONGEUR, 2MM
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: paul holbrook ; 7475 lusk blvd.; san diego, CA 92121 ; 8583205285
• MDR Report Key: 4925787
• MDR Text Key: 6030773
• Report Number: 2031966-2015-00039
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/13/2015

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 Number: 6940429
• Device Lot Number: FD3573403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/13/2015
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 69 YR