MAUDE Adverse Event Report: SYNTHES USA XRL MEDIUM ENDPLATE 21MM X 24MM/5 DEG-STERILE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 08.807.234S

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problems Pulmonary Embolism (1498); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient weight is unknown.Exact date of post-operative device migration is unknown; however, the issue was discovered during a hospital visit on (b)(6) 2016.(b)(4).At this time, it is unknown if the complainant parts will be returned for evaluation.(b)(4).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

Event Description

It was reported that an expandable radiolucent (xrl) medium endplate implant migrated post-operatively requiring revision.The patient originally underwent a corpectomy at t8-t10 on (b)(6) 2016 that involved the insertion of an xrl medium trial implant.The surgeon noted that an 80mm implant would be needed in order to fill the patient's void.As such, an xrl medium central body and two (2) xrl medium endplates (21mmx24mm/5 degrees and 21mmx24mm/10 degrees) were selected.The endplates were correctly secured to the central body using xrl medium endplate screws that were torqued with an appropriate torque instrument.The fully assembled xrl medium cage was inserted into the void using a spreader.The surgeon checked the assembly under fluoroscopy in both the lateral and the anterior/posterior positions to confirm endplate contact and central positioning.The surgeon reportedly used a depuy spine expedium titanium screw system for supplemental internal fixation.Thereafter, the surgeon bi-laterally compressed the t7 screws to secure the bone contact with the cage.None of the supplemental, multi-level pedicle screws touched the implanted cage.The construct was tightened with an expedium torque wrench and counter torque.The original procedure was completed successfully with no reports of surgical delay.Following the procedure, the patient had multiple routine follow-up ct-scans.However, on (b)(6) 2016, the patient returned to the hospital due to a pulmonary embolism.Ct-scans taken on that date identified that the cage had moved from its original position.The patient was returned to the operating room for revision on (b)(6) 2016.During this second procedure, the cage was removed with the use of an xrl implant holder.The patient was then revised to a longer x-mesh cage that expanded to a maximum length of 90mm.The void at that point had measured 83mm.The surgeon used an expander instrument to examine the xrl medium cage at the back table.It was then noted that the implant had not collapsed and would expand as expected.The explant was measured at its distracted height (80mm) at the back table.The revision was ultimately completed successfully with no reports of delay or additional medical intervention.The patient is currently in recovery and is in stable condition.This report is 3 of 4 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Further clarification was received.Two x-rays and one computed tomography (ct) scan were provided.The dates of when they were taken are unknown.However, one was taken intraoperative and two were taken postoperative.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: XRL MEDIUM ENDPLATE 21MM X 24MM/5 DEG-STERILE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5908106
• MDR Text Key: 53276318
• Report Number: 2520274-2016-14375
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103320
• 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: 08/11/2016

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
• Device Catalogue Number: 08.807.234S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2016
• 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