MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/PLATE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

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

Patient Problems Dysphagia/ Odynophagia (1815); Thrombosis/Thrombus (4440)

Event Date 01/02/2019

Event Type  Injury  

Manufacturer Narrative

Additional narrative: this report is for an unk - cage/plate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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: feng, w.Et al (2019), radiographic evaluation of anterior cervical intervertebral disc herniation treated by zero-cut fusion and titanium plate fusion, chinese journal of tissue engineering research, vol.22 (16), pages 2511-2515.(china).The aim of this retrospective study is to compare the clinical effect of a new zero-p interbody fixation and fusion system and titanium plate with cage interbody fixation and fusion system for treating cervical disc herniation.Between january 2016 to june 2017, a total of 42 patients, 21 patients in each group.In the zero-p group, there were 13 males and 8 females, aged 32-69 years, with mean one (49.19 ± 7.26) years.There were 14 males and 7 females in titanium plate group, aged 31-67 years, with mean one (50.27 ± 8.75) years.According to the surgical method, 21 cases were treated with zero-p interbody fixation and fusion system (zero-p group) and 21 cases with titanium plate with cage interbody fixation and fusion system (titanium plate group).Postoperative treatment were cervical collar fixation for 4-6 weeks, routine use of antibiotics, hormones and dehydration drugs, drainage tube removal one to two days after surgery.The mean follow-up period was unknown.The following the complications reported as follows: titanium plate group: - after implant placement, venous thrombosis occurred in 3 patients.At 1 day after operation, 12 patients (57%) had different degrees of dysphagia.At 3 months after operation, 5 patients (24%) had different degrees of dysphagia.At 6 months after operation, 2 patients (10%) had mild dysphagia.And at 18 months after operation, 1 patient (5%) still had mild dysphagia.Zero-p group: - after implant placement, venous thrombosis occurred in 1 patient.At 1 day after operation, 4 patients (19%) had mild dysphagia.At 3 months after operation, 1 patient (5%) had mild dysphagia.Dysphagia symptoms disappeared in 6 months after operation.This report is for an unknown cage/plate (depuy synthes spine).A copy of the literature article is being submitted with this medwatch.This report is for one (1) unk - cage/plate.This is report 1 of 2 for complaint (b)(4).

• Brand Name: UNK - CAGE/PLATE
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 17032293
• MDR Text Key: 316380644
• Report Number: 8030965-2023-06871
• Device Sequence Number: 1
• Product Code: OVD
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• 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: 05/15/2023
• 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