MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE CEMENT; CEMENT, BONE, VERTEBROPLASTY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

The patient, who is also a doctor, is questioning whether or not confidence cement contains acrylic as he may be allergic.Patient was treated with vertebroplasty implanting confidence in 2011.Between six and seven months following implantation, he developed diffuse itching and rash.He suspects that this represents an allergic reaction to acrylic and is concerned because he is scheduled to receive a second acrylic lens implant during cataract surgery on (b)(6) 2014.

Manufacturer Narrative

The catalog number of the cement is unknown.As a result, the manufacturing site location and 510k number are unknown.A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Cement is in patient.

Manufacturer Narrative

The confidence cement was not returned for evaluation as it remains in the patient.A device history record (dhr) review could not be conducted as the lot number is unknown.A 12 month review of the confidence cement was conducted on the device family based on similar material composition.This analysis found no related complaints.Research fellow review determined that the bone cement contains polymethyl methacrylate which is within a family of polymers known as acrylics.The root cause cannot be positively determined however, it is possible that the patient is allergic to acrylics.If results of the patients allergy testing are provided, a follow up report will be filed to document this additional information.No corrective action/preventive action (capa) is necessary at this time as we are unable to confirm the reported issue or identify the root cause.Therefore, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONFIDENCE CEMENT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3967096
• MDR Text Key: 21488993
• Report Number: 1526439-2014-11724
• Device Sequence Number: 1
• Product Code: NDN
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2014
• 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): Required Intervention