MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PRO-STIM® CORE DECOMPRESSION KIT; BONE VOID FILLER

Catalog Number 86SR-CK15

Device Problems Filling Problem (1233); Device Difficult to Setup or Prepare (1487)

Patient Problem No Information (3190)

Event Date 05/18/2015

Event Type  Injury  

Event Description

Allegedly, the pro-stim did not mix properly and it got hard to push into the syringe within 45 seconds.

Manufacturer Narrative

Investigation not complete.Product has not been returned.Trends will be evaluated.This report will be updated when the investigation is complete.

• Brand Name: PRO-STIM® CORE DECOMPRESSION KIT
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: 1023 cherry road; memphis, TN 38117 ; 901867-414
• MDR Report Key: 4796263
• MDR Text Key: 15394187
• Report Number: 1043534-2015-00028
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• PMA/PMN Number: K083270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 86SR-CK15
• Device Lot Number: 1555990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other