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U.S. Department of Health and Human Services

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

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SYNTHES USA XRL MEDIUM ENDPLATE 21MM X 24MM/5 DEG-STERILE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE Back to Search Results
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.
 
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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 Key5908106
MDR Text Key53276318
Report Number2520274-2016-14375
Device Sequence Number1
Product Code MQP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103320
Number of Events Reported1
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 Number08.807.234S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/11/2016
Initial Date FDA Received08/26/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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