MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: SPINE; PLATE,FIXATION,BONE

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates: spine/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.

Event Description

This report is being filed after the review of the following journal article: yeh, k.T.Et al.(2015), laminoplasty with adjunct anterior short segment fusion for multilevel cervical myelopathy associated with local kyphosis, journal of the chinese medical association, vol.78, issue 6, pages 364-369 (taiwan).The aim of this study is to evaluate a new method of expansive open-door laminoplasty (eolp) with adjunct short-segment acf as a reasonable procedure for adequate decompression, effective local foci removal, and preserving motion for multilevel cervical spondylotic myelopathy (mcsm).From august 2005 to july 2012, a total of 109 patients underwent combined expansive open-door laminoplasty (eolp) and adjunct short-segment acdf.There were 59 males and 50 females with a mean age of 54.6 ± 10.2 years.The implants used were 5 pieces of prebent titanium miniplates (ao; synthes, west chester, pa, usa).All of the patients received c3e7 laminoplasty at five levels.Anterior decompression was performed on one motion segment in 65 cases and on two motion segments in 44 cases.Among the 153 acdf levels, allogenous strut bone grafts were used for 45 levels, autogenous tricorticate iliac bone grafts for 38 levels, and polyetheretherketone cages for the other 70 levels.All cases were followed up for at least 12 months.The following complications were reported as follows: 5 patients exhibited temporary swallowing difficulties, but recovered within 1 month.3 patients exhibited temporary dysphonia, but recovered within 2 weeks.This report is for an unknown synthes prebent titanium miniplates.This report is for one (1) unk - plates: spine.This is report 3 of 10 for (b)(4).

• Brand Name: UNK - PLATES: SPINE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11412411
• MDR Text Key: 234710496
• Report Number: 8030965-2021-01601
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1