MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PRO-DENSE(R) INJECTABLE BONE GRAFT; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number 87SR-0410

Device Problems Difficult to Insert (1316); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly,there was an issue with the insertion of prodense. although all steps of the manual where followed precisely, there were difficulties getting enough prodense intothe syringe (like 7cc out of a 15cc batch). therefore the void in the femoral head wasn't filled sufficiently.There was a slight delay due to the error.

• Brand Name: PRO-DENSE(R) INJECTABLE BONE GRAFT
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• 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 ; 9014516318
• MDR Report Key: 7859927
• MDR Text Key: 119691483
• Report Number: 1043534-2018-00124
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K060011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/02/2021
• Device Model Number: 87SR-0410
• Device Lot Number: 1628652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/16/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/16/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1