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

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

Patient Problems Nerve Damage (1979); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 may 2005 and august 2007.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.

Event Description

This report is being filed after the review of the following journal article: chen, y.Et al (2013), significance of segmental instability in cervical ossification of the posterior longitudinal ligament and treated by a posterior hybrid technique, archives of orthopaedic and trauma surgery, vol.33 (xx), pages 171¿177 (china).The aim of this retrospective cohort case study is to evaluate significance of segmental instability (si) in cervical ossification of the posterior longitudinal ligament (opll) myelopathy and effectiveness of a posterior hybrid technique in the treatment of opll associated with si.Between may 2005 and august 2007, a total of 15 patients (11 male and 4 female) with a mean age of 58.4 ± 6.3 years (ranging from 51 to 73 years) were diagnosed with multilevel (c3 levels) opll associated with (si).Another 15 cohort patients (10 male and 5 female) with a mean age of 56.5 ± 4.9 years (ranging 46¿75 years), were without si, and were included in the control group.All patients underwent unilateral open-door laminoplasty with titanium arch miniplates (synthes, switzerland).For patients with si, in addition to laminoplasty, lateral mass screw fixation (competitor device) was also performed.The mean follow-up period was unknown.The following complications were reported as follows: opll with si group: 1 case developed unilateral c5 palsy during the 12¿24 h postoperatively.Opll without si group: in 4 cases, postoperative kyphotic change of the cervical spine was observed at the 4-year follow-up point.In 2 cases, progression of the ossified lesion was observed at the 4-year follow-up point.1 case developed unilateral c5 palsy during the 12¿24 h postoperatively.3 cases developed late neurological deterioration.Of these, neurological deterioration factor were postoperative kyphotic change in 2 cases, and postoperative progression of the ossified lesion in 1 case.This report is for an unknown synthes spine plates and unknown synthes spine 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): 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: 11416471
• MDR Text Key: 239781340
• Report Number: 8030965-2021-01632
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• 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: 02/09/2021
• 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
• Patient Outcome(s): Required Intervention