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); Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown 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: song, k.J., choi, b.W.And kim, j.K.(2014), adjacent segment pathology following anterior decompression and fusion using cage and plate for the treatment of degenerative cervical spinal diseases, asian spine journal, vol.8(6), pages, 720-728 (south korea).The purpose of this study is to analyze the incidence and prevalence of clinical adjacent segment pathology (casp) following anterior decompression and fusion with cage and plate augmentation for degenerative cervical diseases.From january 2002 to may 2010, a total of 231 patients (137 males and 94 females) with an average age of 54.37 were treated with a cervical spine locking plate (ao north america, paoli, pa, usa).The cases were divided into two groups of casp group, for those with development of casp, and the disease-free (df) group.The follow-up duration was 63.85 months (range, 36.0¿123.6 months).The following complications were reported as follows: a (b)(6)-year-old female complained of a recurrent right radiating symptom and she also complained of chronic dysphagia after the first operation.The mri showed adjacent c6-c7 level root decompression.15 patients had casp after the first surgery.At the 8-year follow-up, the average annual incidence of casp was 1.1%.Df survival based on the kaplan-meier survival analysis was 93.6% at 5 years and 90.2% at 8 years.An increase in lordosis was observed in both groups compared to preoperative sagittal alignment.119 patients had radiological degenerative changes, of which 15 developed adjacent segment disease (asdz).This is report 2 of 4 for (b)(4).This report is for 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: 9111323
• MDR Text Key: 164272123
• Report Number: 8030965-2019-68623
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• 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: 08/29/2019
• 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
• Patient Age: 38 YR