MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - MONO/POLYAXIAL SCREWS: CLICK'X; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problems Hematoma (1884); Paresis (1998); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown pedicle screws / unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review / investigation.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: ricarda lechner et.Al (2017), fusion rate and clinical outcome in anterior lumbar interbody fusion with beta-tricalcium phosphate and bone marrow aspirate as a bone graft substitute.A prospective clinical study in fifty patients, international of orthopaedics vol.41(2), pages 333-339 (austria).The aim of this study is to assess the safety and efficacy of b-tricalcium phosphate (b-tcp) in instrumented anterior lumbar interbody fusion (alif) procedure.A total of 50 patient (31 males and 19 females) age ranges 18 and 80 years old were included in the study.These patients had lower-back pain and degenerative disc disease (ddd) or degenerative spondylolisthesis between l3 and s1 and were treated with syncage synthes and unknown synthes pedicle screw.The mean duration of follow-up was 12 months.The following complications were reported as follows: 1 patient had paresis l5.1 patient had hematoma.1 patient had vessel lesion.14 levels showed inadequate fusion anteriorly, (5 pseudoarthrosis, 9 probably not fused).8 patients had pseudoarthrosis at 3 months x-ray assessment.1 patient had pseudoarthrosis at 12 months x-ray assessment.34 patients had probably not fused at 3 months x-ray assessment.19 patients had probably not fused at 6 months x-ray assessment.8 patients had probably not fused at 12 months x-ray assessment.1 patient had migration of cage.This is report 2 of 3 for (b)(4).This report is for unknown synthes pedicle screws.

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: CLICK'X
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 9135540
• MDR Text Key: 160692961
• Report Number: 8030965-2019-68849
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• 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: 09/06/2019
• 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