MAUDE Adverse Event Report: SYNTHES SELZACH VERTECEM II MIXING KIT-STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 08.702.017S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Apnea (1720)

Event Date 10/02/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional product code: lod device history records was conducted.He report indicates that the: manufacturing site: (b)(4), supplier: (b)(4), manufacturing date: 04.Sep.2014, expiry date: 01.Nov.2015, no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It is reported patient was undergoing a kyphoplasty procedure at a surgery center.Patient was in prone position, providing surgeon needle access to l1 and l2.Patient was injected with cement at l1.It is reported anesthesiologist noticed the monitoring machine was not functioning and instructed surgeon to flip the patient.Once flipped, it was noticed the patient had stopped breathing.Procedure was stopped and patient was resuscitated.Patient was then transported via ambulance to an unknown hospital.It is reported patient was released from the hospital and is doing well.This report is 1 of 1 for (b)(4).

• Brand Name: VERTECEM II MIXING KIT-STERILE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5153047
• MDR Text Key: 28382797
• Report Number: 3000270450-2015-10206
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 10/02/2015

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: Health Professional
• Device Expiration Date: 11/01/2015
• Device Catalogue Number: 08.702.017S
• Device Lot Number: 4E60050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 91