MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE CONFIDENCE KIT SPINAL CEMENT SYSTEM - NO NEEDLE; CEMENT, BONE, VERTEBROPLASTY

Model Number 283913000

Device Problem Leak/Splash (1354)

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

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Review of the device history record identified no issues during the manufacturing or release of the product that could be attributed to the problem reported by the customer.The product was released accomplishing all quality requirements.Awaiting sample: 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

During an l2 vertebroplasty using confidence cement it was noticed by the surgeon that the cement was not being delivered as normal.The cement was within normal working times and the connection between the hydraulic pump and the cement reservoir were checked.The surgeon described a hissing sound on turning the pump handle.The hydraulic pump was checked and it was noticed there was liquid escaping behind the seal on the plunger of the hydraulic pump.

Manufacturer Narrative

The confidence spinal cement kit was not returned for evaluation.Review of the device history record identified no issues during the manufacturing or release of the product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.Without the return of the kit, the root cause cannot be identified.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends have been observed, 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 KIT SPINAL CEMENT SYSTEM - NO NEEDLE
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6757484
• MDR Text Key: 81511380
• Report Number: 1526439-2017-10624
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)10705034209630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060300
• 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: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 283913000
• Device Catalogue Number: 283913000
• Device Lot Number: 133828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1