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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.This report is for an unknown synthes synfix-lr/unknown lot.Part and lot number are unknown; udi number is unknown.510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter¿s phone number is unknown.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: lee, h and lee, s.(2017), the usefulness of synfix-lr in trouble case, global spine journal, vol.7(2s) pages 250s (korea).The purpose of this study is to introduce the usefulness of synfix-lr in difficult cases.Between january 2011 and may 2014, 28 patients (13 male and 15 female), with mean age of 66.7 years underwent anterior lumbar interbody fusion (alif) using unknown synthes synfix-lr.Follow-up was done in 1 month, 3 months, 6 months and 1 year.The following complication were reported as follows: 10 patients had severe modic change and endplate sclerosis and vacuum disc.Anterior screwing at the contact between cage and endplate was enforced to achieve cage stability.Seven patients had endplate irregularity due to previous vertebral compression fracture.One patient had fused vertebra at l4, l5, s1.Pedicle screw fixation had some difficulty.Additional anterior screws were used.Three patients had interspinous device and developed back pain.These patients underwent alif with anterior screws.Unknown patients had large dimple at vertebral body.In those patients, dimple was filled with allograft and anterior screwing was used for holding cage.Five patients had high sacral slope and listhesis wherein s1 body shape became ball surface.This could predict cage instability and non-union.Anterior screwing was performed for adding stability.Two patients had pedicle anomaly.Posterior pedicle screwing was not possible.One case of cage subsidence.This report is for 3 patients who had interspinous device and developed back pain.This report is for an unknown synthes synfix-lr this is report 1 of 2 for (b)(4).

• 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: 7891395
• MDR Text Key: 120832238
• Report Number: 8030965-2018-56464
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• 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