MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONFIDENCE HIGH VISC SPINAL CEMENT, 11CC; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 183901000

Device Problem No Flow (2991)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/27/2014

Event Type  Injury  

Event Description

The surgeon was injecting spinal cement through a confidence kit vertebroplasty needle.When the surgeon finished injecting cement, he started to put the plunger to the needle but the plunger did not enter on the needle.Immediately the surgeon tried to remove the needle from the vertebral body but it was impossible because the cement had set in less than 4 minutes.The patient was given general anesthesia and a larger incision was made to cut the two vertebroplasty needles with a reamer at the level of the facet joints.The vertebroplasty needles were left in the vertebra of patient.The difficulty resulted in a delay of sixty minutes to the procedure.

Manufacturer Narrative

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.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Neither the confidence high viscosity spine cement nor the concomitant device confidence spinal cement system was returned for evaluation.A review of the supplier device history record for the cement found no anomalies were observed during the manufacturing process.Additionally, a review of the dhr for concomitant confidence spinal cement system confirmed the lot met specifications.As such, no issues were identified during the manufacturing and release of this product that could have been contributed to the problem reported by the customer.A 12-month review of the complaint trend analysis for the high viscosity cement catalog number 183901000 found no emerging trends.Without the product device we are unable to confirm the reported issue or identify the root cause.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 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 HIGH VISC SPINAL CEMENT, 11CC
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): TEKNIMED SAS; 325 paramount drive; vic en bigorre MA 02767 655; FR 02767 6550
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3705616
• MDR Text Key: 4232401
• Report Number: 1526439-2014-11420
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 183901000
• Device Lot Number: 043D13082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 03/27/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/01/2014; 06/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2013
• 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
• Treatment: CONFIDENCE KIT, 283910000
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR