MAUDE Adverse Event Report: SYNTHES USA 4.0MM TI LOCKING SCREW 25MM FOR SYNFIX(TM)-LR; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Catalog Number 04.802.202

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

Patient Problems Sedation (2368); Blood Loss (2597); No Code Available (3191)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.Complained device is not expected to be returned for manufacturer review/investigation, as device was discarded by the facility.(b)(4).It was reported the screw pierced the iliac vein during insertion.The surgeon removed the screw and repaired the iliac vein.There was no reported malfunction of the screw.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.

Event Description

It was reported that on (b)(6) 2016, a patient underwent surgery for the implantation of a synfix device and four, 4.0mm ti locking screw 25mm for synfix-lr screws at level l5-s1.As the patient was being closed up, the exposure surgeon noticed that the superior screw on the patient¿s left side was visible on the anterior and lateral aspect of the l5 vertebral body.It was reported that the implanting surgeon returned to remove the screw and as he did, it was determined that the screw had pierced the iliac vein.Steps were taken by the surgeon to repair the vessel resulting in a 90 minute delay in surgery.It was also reported that the patient had an approximate loss of a liter of blood.The patient was not given blood during the procedure and it is unknown if a transfusion was required postoperatively.The screw that was removed was not replaced and therefore, the patient currently has the synfix device and 3 screws implanted.The remainder of the surgery was completed without further incident and the patient was reported as stable.Concomitant device: synfix(tm)-lr 26mm depth/32mm width/13.5mm height 12deg-ster (part #08.802.004s, lot # unknown, quantity 1).4.0mm ti locking screw 25mm for synfix(tm)-lr (part #04.802.202, lot # unknown, quantity 3).This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

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: 4.0MM TI LOCKING SCREW 25MM FOR SYNFIX(TM)-LR
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6167666
• MDR Text Key: 62195170
• Report Number: 2520274-2016-15660
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072253
• 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,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.802.202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FOUR 4.0MM TI LOCKING SCREW FOR SYNFIX(04.802.202); ONE (1) SYNFIX(TM)-LR (08.802.004S)
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR