MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS; SCREW, FIXATION, BONE

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/ 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.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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: lin gx, et al.(2019), time course observation of outcomes between minimally invasive transforaminal lumbar interbody fusion and posterior lumbar interbody fusion, neurol med chir (tokyo), volume 59, pages 222-230, (south korea).The purpose of our study is to compare patient outcomes, spinal fusion, and incidence of complications between mis-tlif and o-plif for comparison between mis-tlif and plif 223 neurol med chir (tokyo) 59, june, 2019 treatment of single-level lumbar spine pathology at a minimum of 5-year follow-up.From march 2010 to july 2013, 34 patients (mean age of 65.4 +/-7.6 years; range from 51 to 81 years) who underwent single-level minimally invasive transforaminal lumbar interbody fusion (mis-tlif) and 36 patients (mean age of 5.8 +/- 0.9 years; range from 5 to 8 years) who underwent single-level open posterior lumbar interbody fusion (o-plif) were included in the study.Patients in mis-tlif group were implanted with a single cage using either an unknown synthes opal cage or with competitors' devices.Meanwhile, patients in o-plif group were implanted with 2 cages using either an unknown synthes plivios cage, unknown synthes opal cage or competitors¿ device.Patients were evaluated at 6-month, 2- and 5-year follow-up intervals.Complications were reported as follows: (mis-tlif group): 1 patient had dural tear and pulmonary thromboembolism and was referred to cardiology department.1 patient had symptomatic screw malposition which required revision surgery.1 patient had bone graft dislodgement.4 patients had adjacent segment degeneration (asd), none of which required surgery.2 patients had pseudoarthrosis.10 patients had cage subsidence 5 years after surgery.Unknown patients had back pain.Unknown patients had leg pain.(o-plif group): 1 patient developed epidural hematoma, which required emergency surgical evacuation.1 patient had asymptomatic osteolysis and was managed by observation alone.12 patients had adjacent segment degeneration (asd).4 of these patients required surgery to address clinical symptoms caused by asd.1 patient underwent o-plif revision surgery, 2 patients underwent mis-tlif revision surgery (fig.1), and 1 underwent minimally invasive discectomy (fig.1) a (b)(6) year-old female had an adjacent segment degeneration (asd).After 6 years, patient underwent revision with minimally invasive transforaminal interbody fusion at l3¿4 and minimally-access plif at l4¿l5.3 patients had pseudoarthrosis.9 patients had cage subsidence 5 years after surgery.Unknown patients had back pain.Unknown patients had leg pain.This report is for the unknown synthes screws.It captures the reported event of screw malposition.This is report 2 of 6 for complaint (b)(4).

• Brand Name: UNK - SCREWS
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9654133
• MDR Text Key: 190627421
• Report Number: 8030965-2020-00768
• Device Sequence Number: 1
• Product Code: HWC
• 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: Physician
• Type of Report: Initial
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• 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: 01/13/2020
• 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