MAUDE Adverse Event Report: SYNTHES SELZACH MATRIX LOCKING CAP WITHOUT SADDLE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 09.632.099S

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

Patient Problem Death (1802)

Event Date 01/27/2015

Event Type  malfunction  

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 7 of 8 for (b)(4).

Manufacturer Narrative

Additional product codes for non-sterile part: mnh, mni, kwq, kwp.Lot numbers reported as 9101701, 9133432, 9203287.The exact lot number is not known.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

(b)(4): device history records was conducted.The report indicates that the investigation could not be completed; no conclusion could be drawn, as no product was received.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.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

The complainant part for this report is a sterile part with part number 09.632.099s.The lot number for this sterile part is one of two possible sterile lot numbers: 9101701 or 9203287.For lot number 9101701 ¿ august 1, 2024.For lot number 9203287 ¿ october, 1, 2024.For lot number 9101701 ¿ august 18, 2014.For lot number 9203287 ¿ october 20, 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.

• Brand Name: MATRIX LOCKING CAP WITHOUT SADDLE
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA 19380 CH2; SZ 19380 CH25
• 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: 4519360
• MDR Text Key: 5406644
• Report Number: 2520274-2015-10966
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120838
• 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
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.632.099S
• Device Lot Number: 9203287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2015
• Initial Date FDA Received: 02/16/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/09/2015; 04/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1