MAUDE Adverse Event Report: SYNTHES SELZACH VERTEBRAL AUGMENTATION ACCESS KIT; DISPENSER, CEMENT

Catalog Number 03.804.512S

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2012

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: this complaint was part of a market preference evaluation which records the complaint aspects of 2010 mpe results.The vertebral body stenting (vbs) was used during a study.It was reported that on (b)(4) 2012, the vertebral body stenting (vbs) cannula has broken under the pedicle entrance level.The broken part of the cannula was left in the vertebral body / pedicle.It was reported that the patient had completely recovered.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional product codes: fzx, hxg, htw, mjg.Device is an instrument and is not implanted/explanted.A device history review was conducted.The report indicates that no ncrs were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Clinical reference number: (b)(4) (vbs vertebral body stenting (b)(4)).Device was 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.

• Brand Name: VERTEBRAL AUGMENTATION ACCESS KIT
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4121011
• MDR Text Key: 4796917
• Report Number: 3000270450-2014-10110
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/31/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: 03.804.512S
• Device Lot Number: AJW301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR