MAUDE Adverse Event Report: SYNTHES USA TI COLLAR WITH GROOVES

Catalog Number 498.011

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583); Device Slipped (1584); Split (2537); Malposition of Device (2616); Device Damaged by Another Device (2915); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Patient was implanted with universal spine system (uss) construct posteriorly from l4-s1 skipping level l5 on (b)(6) 2008 for an l5 hemangioma.On (b)(6) 2008 patient was implanted with synex cage at l5 from an anterior approach.Initially, the surgeon thought the synex cage appeared to look like it might be crooked or tilted (event captured in complaint # (b)(4)).Patient returned to the operating room (or) on (b)(6) 2013 for revision surgery.The surgeon performed a posterior revision on the patient on (b)(6) 2013.The surgeon reported the patient had a nonunion and the patient complains of back pain that has become worse in the past three (3) months.Reportedly the patient has had pain for the past few years.The surgeon removed the entire uss construct.Patient was revised to a new uss construct.The surgeon also extended the levels to l3-ilium while skipping l5.During the removal, the s1 screws were reportedly very loose in the pedicles and were easily removed.The l4 screws were solidly anchored in the bone but were removed and replaced with longer screws.The surgeon plans to achieve a solid posterior fusion and leave the synex cage as it is in l5.The new posterior hardware spans from l3-ilium.It was reported all of the posterior hardware was intact.During the posterior revision surgery on (b)(6) 2013, while connecting the rod to the right iliac screw, the nut was cross-threaded on the screw, and damaged the screw.The nut and screw were replaced, and then engaged properly.In addition, the graft pusher handle split when impacted with the mallet, as the surgeon was performing the interbody fusion at l3-l4 with the transforaminal posterior lumbar interbody fusion (t-plif) spacer set.All pieces of the broken handle were retrieved, and another sterile set was available to retrieve another graft pusher.There was less than 15 minute delay total for the cross-threaded nut and screw, and the broken graft pusher handle.Surgery was completed.This is 11 of 16 reports for the same event, complaint # (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.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.Placeholder.

Event Description

Updated description: it was reported that the patient has had a total of seven (7) procedures to address his spine anatomy issues.In (b)(6) 2006 surgery was performed at l5 disc space to cut off blood supply to the reported hemangioma.On (b)(6) 2008, an l5 posterior resection was performed, due to a hemangiomac, with an l4-s1 posterior fusion using the (uss) universal spine system implants.On (b)(6) 2008 patient was brought back to the operating room for a follow-up procedure, where the patient was implanted with an synex cage implant at the l5 spine disc space level to again address the disc space where the hemangioma was removed.On (b)(6) 2008, the surgeon performed an irrigation and debridement procedure due to patient infection.In (b)(6) 2011, the patient fell at work which caused him considerable back pain.On (b)(6) 2013, the surgeon removed all uss implants that were originally implanted on (b)(6) 2008, due to patient pain.During this procedure, the synex cage implant was left in place at the l5 disc space.On (b)(6) 2015, another revision surgery was performed due to a non-union, patient pain, and synex cage failure.This revision included an l5 corpectomy, l4-s1 anterior fusion.The patient was revised to a stryker v-lift cage and bone void filler at l5 disc level.In (b)(6) 2015, the patient had a tripping incident at home, where he caught himself before completely falling to the ground.After this incident, the patient heard clicking sounds during movement.On (b)(6) , 2016, a third revision surgery was performed due to posterior spinal fusion rod breakage.Surgeon replaced and revised the patient to new rods and replacement of loose screws.Concomitant devices: ti low profile trans connector 56m/83mm (item number 497.799, lot number unknown, quantity 2 each).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10: additional narrative: patient height reported as 6 feet.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: TI COLLAR WITH GROOVES
• Manufacturer (Section D): SYNTHES USA; west chester PA
• MDR Report Key: 3596744
• MDR Text Key: 17386908
• Report Number: 2520274-2014-00044
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K951794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Type of Report: Initial,Followup
• Report Date: 12/31/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 498.011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 132