MAUDE Adverse Event Report: SYNTHES (USA); ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).This report is for two (2) unknown uss dual opening 6.0mm rods.Part and lot numbers were not available for reporting.Implanted date, therapy date: date of implant is unknown and was reported as an unknown date in 2013.The complaint device is not expected to be returned to the synthes manufacturer for evaluation.510(k): unknown.(b)(4).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.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 revision surgery was performed on (b)(6) 2016 due to broken hardware, pain and non-union.The patient had a c6-t12 posterior spinal fusion on an unknown date in 2013 during which time the synthes synapse 4.0mm rod system from c6-t4 and the dual opening universal spine system (uss) from t6-t12 were implanted.On an unknown date, the uss dual opening (do) 6.0mm rods between t4 and t5 broke post-operatively.There was no implant at level t5 at the transition from synapse to uss dual opening.Additionally the right c6 unknown synapse screw at the base of the head broke post-operatively.The right t4 unknown synapse screw at the base of the head of the screw, also broke post-operatively.The surgeon attributed the breaking of the rods and screws due to non-union.During the (b)(6) 2016 revision surgery the surgeon attempted to remove all of the synapse hardware.The broken synapse screws at right c6 and right t4 could not be fully retrieved; the screw fragments remained in the patient.The surgeon removed the t6 uss dual opening screws and cut the rods in situ at approximately the t6 level.The surgeon cut the rods a little shorter with a metal cutting burr to make room for the rods to connect to the rod connectors used to complete the procedure.Fragments were generated during the rod cutting.Use of the metal cutting burr generates debris, so the surgeon used a sterile ultrasonic lubricant to catch the shavings and then suctioned the rod shavings.There were also two broken pieces at the cranial part of the 6.0mm rod that were retrieved from the top of the construct.Most of the rod remains in the patient.He then the hardware from levels c7-t5 was replaced with a depuy expedium 5.5mm rod system.The surgeon did not think that the patient needed the c6 screws.The new expedium rods were placed and the expedium construct was connected to the uss dual opening construct with synthes extension connectors.The surgery was successfully completed and there was no surgical time delay.The patient's postsurgical status was reported as "fine".This report is for two (2) unknown uss dual opening 6.0mm rods.This report is 1 of 3 for (b)(4).

• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5866920
• MDR Text Key: 51814812
• Report Number: 2520274-2016-14026
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 07/21/2016

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/10/2016
• 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
• Patient Outcome(s): Required Intervention