MAUDE Adverse Event Report: SYNTHES MONUMENT; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Catalog Number SRS-010-RMS

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354)

Patient Problems Inflammation (1932); Pain (1994); Swelling (2091)

Event Type  Injury  

Event Description

Complaint handling unit received a maude report forwarded from j&j legal department for medwatch #(b)(4).Only additional and/or corrected information will be contained in this report.A copy of the maude event report is attached.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records was conducted.The report indicates that the: (b)(4) manufactured the srs bone void filler rotary mix 10cc - sterile, p/n srs-010-rms, and lot #n000828 for po #1271675.The lot conformed to (b)(4) (closed may 9, 2011) and synthes purchase order (b)(4)(released june 3, 2011).There were no mrr¿s or ncr¿s generated for this lot.Brand name: norian srs-010-rms 10cc bone void filler.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: FILLER, CALCIUM SULFATE PREFORMED PELLETS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4268912
• MDR Text Key: 15908008
• Report Number: 1719045-2014-10616
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2013
• Device Catalogue Number: SRS-010-RMS
• Device Lot Number: N000828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2011
• 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
• Patient Outcome(s): Other; Required Intervention