MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11 CC; CEMENT, BONE, VERTEBROPLASTY

Model Number 283910000

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot 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.Device not yet returned for evaluation.

Event Description

It was reported that during a posterior lumbar fusion a second cement kit had to be opened because of a defective component in the mixing apparatus.Additional info: on (b)(6) 2017 it was reported that the packet inside the box that contains the mixing bowl , mixer handle, cement reservoir adapter and cement reservoir were missing from this box, rendering the product unusable.

Manufacturer Narrative

Further review with the quality engineer, determined this event is not considered a reportable malfunction.Even though cement components were missing, there was a back up kit available to successfully complete the procedure.There was no report of delay or adverse consequence to the patient.The confidence kit is a single use sterile product and standard practice is to have a backup kit(s) available.If this type of event were to reoccur, it is likely that another kit would be available as in this instance.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11 CC
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6794704
• MDR Text Key: 82702128
• Report Number: 1526439-2017-10650
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: (01)10705034209623
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

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: Physician
• Device Model Number: 283910000
• Device Catalogue Number: 283910000
• Device Lot Number: 129821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 09/14/2017
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1