MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKNOWN BIOMATERIAL - CEMENT; CONFIDENCE CEMENT, BONE, VERTEBROPLASTY

Catalog Number UNK BIOMATERIAL - CEMENT

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi: (01)unknown-(10)unknown.The unknown biomaterial-cement was not returned to the complaint handling unit (chu).A review of the device history record was not possible as a lot number was not available.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.No issues could be identified in the manufacturing or release of this product since the lot number could not be identified.Therefore, this complaint will be closed with no further action required.If more information and/or the complaint device become available at a later date, the complaint will be reopened and the product will be evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After mixing the polymer and the monomer, the cement was too hard to go out of the needle.Patient consequence? no.

• Brand Name: UNKNOWN BIOMATERIAL - CEMENT
• Type of Device: CONFIDENCE CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; SZ
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7348598
• MDR Text Key: 102813574
• Report Number: 1526439-2018-50245
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK BIOMATERIAL - CEMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2018
• 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