MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown synthes oracle lumbar polyetheretherketone cage/spacers/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used to capture additional medical/surgical intervention required.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.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: belykh, e.Et al (2018), facet joint fixation and anterior, direct lateral, and transforaminal lumbar interbody fusions for treatment of degenerative lumbar disc diseases: retrospective cohort study of a new minimally invasive technique, world neurosurgery, vol.114 pages e959-e968 ((b)(6)).The primary objective of this retrospective observational cohort study is to assess the initial experience with a new technique for facet joint fixation using a wedge-shaped cage plate.Between october 2014 and october 2015, 80 patients were included in the study.These patients were divided into three groups; anterior lumbar interbody fusion group with 24 patients using a competitor device, direct lateral interbody fusion group with 26 patients (19 male and 7 female) with a mean age of 39 years, using an unknown synthes oracle lumbar polyetheretherketone cages (depuy synthes (b)(4)) and the transforaminal lumbar interbody fusion group with 30 patients (21 male and 9 female) with a mean age of 44 years using an unknown synthes t-pal titanium cages (depuy synthes).Ipsilateral percutaneous pedicle screw stabilization was performed using the viper 2 system (depuy synthes).All facet joint fixations were performed using cage plates (facet wedge [depuy synthes).Follow-up was done in 3, 6, and 12 months.The following complication is associated with direct lateral interbody fusion: 1 patient had submuscular hematomas.1 patient had surgical wound infection which resolved with antibiotics.1 had adjacent level degeneration in which the degenerative process had progressed in the adjacent segment at follow-up 1 patient had failure of fixation construct.1 patient fell from a height of 3m 5 months after surgery, resulting in failure of the facet fixation.The following complication is associated with transforaminal lumbar interbody fusion: 1 patient had a dura incident which was torn, that required microsurgical suturing and fibrin glue application to prevent postoperative cerebrospinal fluid leakage.1 patient had submuscular hematomas.1 patient had surgical wound infection which resolved with antibiotics.1 had adjacent level degeneration in which the degenerative process had progressed in the adjacent segment at follow-up 1 patient had worsening of neurologic symptoms as a result of scarring or epidural fibration.1 patient had pain recurrence 4.5 months after surgery caused by postoperative adhesive epidural inflammation, which was treated conservatively.This report is for failure of fixation, the device broke post-op requiring additional surgical intervention.This report is for an unknown synthes oracle lumbar polyetheretherketone cage/spacers this is report 3 of 3 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7899512
• MDR Text Key: 121439517
• Report Number: 8030965-2018-56566
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• 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?: Yes
• Date Manufacturer Received: 08/29/2018
• 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