MAUDE Adverse Event Report: SYNTHES MONUMENT CRS FAST SET PUTTY 10CC BONE CEMENT-STERILE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Catalog Number 613.10.01S

Device Problem Crack (1135)

Patient Problems Foreign Body Sensation in Eye (1869); Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Per the facility, all of the removed product was discarded and is not available for evaluation.The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing date: february 15, 2006 ¿ expiration date: december 31, 2007.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a revision of a cranioplasty was performed on (b)(6) 2015.The patient underwent an original procedure due to fibrous dysplasia on (b)(6) 2005.Approximately one (1) year ago, the patient complained of loose fragments moving around.Computerized tomography (ct) scan done on an unknown date showed broken pieces of (b)(4).The revision procedure revealed that the superficial portion of the (b)(4) had crumbled and broken (approximately 10%) while the portion underneath remained intact.The surgeon opted to remove all of the (b)(4) and replace with a custom, cranial implant.The revision procedure was completed successfully without incident.There were no surgical delays and no additional medical intervention required.This report is 2 of 2 for (b)(4).

• Brand Name: CRS FAST SET PUTTY 10CC BONE CEMENT-STERILE
• 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: 5214484
• MDR Text Key: 30970770
• Report Number: 1719045-2015-10724
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2007
• Device Catalogue Number: 613.10.01S
• Device Lot Number: N704500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention