MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problems Dysphagia/ Odynophagia (1815); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cervical spine 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: kyung-jin song, kwang-bok lee, and ji-hoon song (2012), efficacy of multilevel anterior cervical discectomy and fusion versus corpectomy and fusion for multilevel cervical spondylotic myelopathy: a minimum 5-year follow-up study, european spine journal vol.21 (8), pages 1551-1557 (korea south).The aim of this study was to evaluate the radiologic and clinical outcomes to compare the efficacy of anterior cervical discectomy and fusion (acdf) and anterior corpectomy and fusion (accf) for multilevel cervical spondylotic myelopathy (csm).Between 1994 and 2003, a total of 40 patients were included in the study.The patients were divided into 2 groups.Group a has 25 patients (19 males and 6 females) with the mean age of 50.3 years (ranges 42 ¿ 73 years) who underwent multilevel acdf.Group b has 15 patients (11 males and 4 females) with the mean age of 54.1 years (ranges 45 ¿ 70 years) who underwent multilevel accf.Both groups were treated with cslp (cervical spine locking plate).The mean duration of follow-up of group a was 87.3 month and group b was 94.3 months.The article captures the following complications: (b)(6) years old man has developed cervical kyphosis and the formation of ald on the 8 years postoperative follow up lateral x-ray.Group a: 16 patients had the adjacent level disease.2 patients had revision surgery.3 patients had pseudoarthrosis, 2 patients had pseudoarthrosis in smokers, 3 patients had dysphagia, 2 patients had hoarseness, 1 patient had donor site pain.Group b: 8 patients had the adjacent level disease.1 patient had revision surgery.1 patient had pseudoarthrosis, 1 patient had pseudoarthrosis in smokers, 3 patients had dysphagia, 2 patients had hoarseness, 4 patients had donor site pain, 2 patients had graft related complication.4 patients had a dural tear.2 patients had hardware-related complications, (including screw back-out or plate bending).In group a.This is report 4 of 6 for (b)(4).This report is for an unknown synthes cervical spine screws.

• Brand Name: UNK - SCREWS
• 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: 9153531
• MDR Text Key: 165376406
• Report Number: 8030965-2019-68991
• Device Sequence Number: 1
• Product Code: NKB
• 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: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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: 09/11/2019
• 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