MAUDE Adverse Event Report: SYNTHES SELZACH 6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.632.640S

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

Patient Problem Death (1802)

Event Date 01/27/2015

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: lot: 7630989.Additional dhr information: non-sterile part - manufacture date: 3-14-14, part was manufactured in the us: article: (b)(4).The sterile information does not have any connection to the reported problem.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis additional narrative: a review of the device history records was performed and no complaint related issues were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Corrected information: (catalog number): the actual complainant part for this report is the sterile part with part number (b)(4).(lot number): the lot number for the complainant part (sterile) is 9008068.The associated non-sterile part had a lot number of 7630989.The manufacturing date for the complainant part (sterile) was june 11, 2014.The associated non-sterile part was manufactured on march 14, 2014.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon inserted 4 pedicle screws after he inserted a cage between vertebral bodies, l4-l5.After that, he placed a rod on one side but the patient¿s condition turned to worse about that time and the surgery was discontinued.The patient deceased the next day.In the surgeon¿s opinion, the patient¿s vein was damaged during the surgery which caused the patient¿s demise.This report is 3 of 8 for (b)(4).

Manufacturer Narrative

Additional product codes for non-sterile part: mnh, mni, kwq, kwp.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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: 6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 4519527
• MDR Text Key: 12988200
• Report Number: 3000270450-2015-10049
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: 04.632.640S
• Device Lot Number: 9008068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1