MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX® EVOLUTION SPACER SMALL/12MM HEIGHT/14°-STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Model Number 08.815.122S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight was not provided for reporting.Device remained implanted.Explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 on (b)(6) 2018, patient underwent initial surgery, an anterior lumber interbody fusion (alif), with non-synthes posterior hardware, two (2) synfix evolution cages, and eight (8) 20mm screws due to patient had rare case spondyloptosis.The patient underwent a revision on (b)(6) 2018 for a full corpectomy that wasn't completed during the initial surgery, not implanted related.The surgeon had some significant challenges during the revision.Initially he attempted to use the straight driver with the aiming device loaded on the implant.This resulted in the tip being torqued out.He then tried another straight driver without the aiming device loaded and was unable to loosen the screw.He then placed the aiming device back onto the implant and attempted to use the articulating drivers.Again, he was unable to loosen the screws and ended up sheering the tips of two drivers.At one point the surgeon used a mallet and attempted to turn and hammer on the straight driver simultaneously which didn¿t break the seal either.Ultimately, he had to use a metal cutting burr to shave/remove the tips of the screws.This resulted in metal fragments being displaced and the use of ky jelly to control temperature.The surgeon was removing the two (2) inferior screws because he was performing a corpectomy of the vertebral body that they were fixed to.The surgeon stated that the torque limiting handle may be set too high.No patient consequence.Surgical delay was fifteen-twenty (15-20) minutes.The patient¿s initial surgery, an anterior lumber interbody fusion (alif), with non-synthes posterior hardware, two (2) synfix evolution cages, and eight (8) 20mm screws, was on (b)(6) 2018 due to patient had rare case spondyloptosis.This complaint captures the intra-operative incident occurred during revision surgery.(b)(4) captures the post-operative event that required revision.Concomitant devices reported: synfix evolution aiming device (part # 03.835.001, lot # unknown, quantity # 1), torque limiting handle (part # 03.835.043, lot # unknown, quantity # 1), mallet (part # unknown, lot # unknown, quantity # 1), synfix evolution screwdriver straight without sleeve (part # 03.835.015, lot # unknown, quantity # 1).This report is for one (1) synfix® evolution spacer small/12mm height/14°-sterile.This is report 3 of 3 for (b)(4).

• Brand Name: SYNFIX® EVOLUTION SPACER SMALL/12MM HEIGHT/14°-STERILE
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7519885
• MDR Text Key: 108495062
• Report Number: 2939274-2018-52213
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 10705034815183
• UDI-Public: (01)10705034815183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08.815.122S
• Device Catalogue Number: 08.815.122S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25 YR