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

Catalog Number 183901001

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2014

Event Type  malfunction  

Event Description

International affiliate reports the confidence cement set too fast at the first mixing step.Affiliate reports there was a resulting delay to the procedure of about ten minutes with no adverse consequences to the patient.

Manufacturer Narrative

Additional 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

The 11cc high viscosity cmw cement was not returned for evaluation.A review of the device history record (dhr) identified no issues during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A 12 month complaint trend analysis for the cement was conducted on the family, as this failure is not limited to this product code.This analysis found no systemic trend requiring further action.The root cause for the cement setting too quickly cannot be positively identified.No corrective action/preventive action is required at this point as there has been no issues identified in the manufacturing or release of this device, and there have been no systematic trend.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.Not returned for evaluation.

• Brand Name: HIGH VISC CMW SPINAL CMT, 11CC
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 38 chemin blanc; lelocle CH-2 400; SZ CH-2400
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3967642
• MDR Text Key: 4612230
• Report Number: 1526439-2014-11728
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2014

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 Catalogue Number: 183901001
• Device Lot Number: 7788236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 07/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: No
• 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: CEMENT RESERVOIR & MIXER, (B)(4)