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

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

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown plate/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between january to december 2016.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.(b)(4).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: liu, x., zhao, z., yang, s., and li, z.(2019), short-term curative effects of arch titanium plate fixation combined with expansive single open-door laminoplasty in treating cervical spondylotic myelopathy, chinese journal of orthopaedics and traumatology, vol.32 (3), pages 278-282 (china).The aim of this study is to evaluate the short term curative effects of arch titanium plate fixation combined with expansive single open-door laminoplasty (eolp) in treating cervical spondylotic myelopathy (csm).Between january to december 2016, a total of 32 patients (23 male and 9 female) with an average of 64.5 years (range 39-82 years) underwent expansive single open-door laminoplasty (eolp).Surgery was performed using arch titanium plates (synthes).All patients received follow-up visits, which lasted 6 to 20 months, with an average of 12.2 months.The following complications were reported as follows: 3 patients had axial symptoms during the follow-up period.This report is for an unknown synthes plates and unknown synthes screws.This report is for one (1) unknown plate.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES: SPINE
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10430865
• MDR Text Key: 203667318
• Report Number: 8030965-2020-06166
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• 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: 07/27/2020
• 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