MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS: CERVIOS; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cage/spacers: cervios/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.Health effect clinical code e2402 used to capture neurological complication.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: hirvonen, t.Et al (2020), anterior cervical discectomy and fusion in young adults leads to favorable outcome in long-term follow-up, the spine journal, vol.20 (7), pages 1073-1084 (finland).The aim of this retrospective cohort study is to study the long-term outcomes of acdf surgery among those members of the young adult population who have been operated on between the ages of 18 and 40.Between 1990 to 2005, a total of 476 patients (289 male and 187 female) with a median age of 37 (22-40) years underwent acdf and included in the study.The analysis was conducted between december 2017 to february 2018.64 patients (13%) underwent only a discectomy (during the years of 1990 to 1999).Interbody fusion with iliac crest autograft was performed on 84 (18%) patients (between the years of 1990 and 1998).For the rest of the patients (328, or 69%), fusion was performed with a synthetic interbody cage (cervios, syncage, acromed, and other competitor devices) (between the years of 1998 and 2005).A total of 430 out of 476 patients (90%) had clinical data available from their follow-up visits (median 67 days, min 15 days, max 340 days).83% of patients had their follow-up visits 2-3 months after surgery.443 patients (93%) were sent with additional questionnaires.Of these patients, 281 (59% of all patients in the study) returned the questionnaires.The median follow-up period was 17.5 years (min 1 year, max 27.9 years).The following complications were reported as follows: 9 patients died before commencement of this follow-up study.24 patients had died during the follow-up period.1.4% of patients had postoperative hematomas.All hematomas but 1 occurred acutely within 24 hours (with 1 occurring on the next day within 36 hours), and all were treated with a hematoma evacuation.4% of patients had persistent dysphonia.2% of patients had dysphagia.4% of patients had new neurological symptoms (typically sensory or motor nerve root symptoms).21/476 patients required reoperation because of complications, with the reasons for such intervention including hematomas (n = 7), new neurological symptoms (n = 9), bone autograft problems (n = 3), and primary operation on the wrong level (n = 3).3 patients were reoperated on in acute settings 2 times (2 because of new neurological symptoms, and one first because of residual disc herniation, and then a bone autograft problem).Overall, 30.8% of all complications led to a reoperation.A total of 33% of the patients were referred back to the huh neurosurgery department at least once for a new consultation regarding cervical spine problems.In 112 patients, 140 new cervical surgeries were performed, either of the index level or of other cervical levels.All of these cervical reoperations were able to be categorized as either early revisions (<28 days from the primary operation) or late surgeries (>28 days).A total of 17% of reoperations (n = 24) were performed at an early period after surgery (<28 days), and these consisted of the aforementioned revision surgeries to deal with postoperative complications.All early reoperations were either anterior decompressions of the same level (58%), hematoma evacuations (29%), or bone autograft removals (8%).13 later operations were done in hospitals other than huh (11 in 4 other finnish university hospitals, and 2 in a private hospital) (table 2).Out of the later reoperations, 17% were performed during the first 2 years.Excluding early revision surgeries (<28 days) from the analysis, the reoperation rate during 10 years was 12.8% and 19.5%.80 patients underwent surgery for asd, and the risk of needing surgery for adjacent level disease was 10.3% in 10 years, and 16.8% for the duration of the entire follow-up (median 17.5 years), with a 1.1% annual incidence rate of adjacent level disease requiring surgery.This report is for an unknown synthes cervios cage.It captures the reported event of new neurological symptoms required reoperation and underwent new cervical surgeries.This is report 1 of 2 for pc (b)(4).

• Brand Name: UNK - CAGE/SPACERS: CERVIOS
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11488908
• MDR Text Key: 242903900
• Report Number: 8030965-2021-01982
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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: 02/16/2021
• 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