MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS: SYNCAGE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problem Migration (4003)

Patient Problems Weakness (2145); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown syncage/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.(b)(4).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: hrabálek, l.Et al (2009), the use of titan and peek implants in stand-alone alif surgery for degenerative disease of the lumbosacral spine ¿ a prospective study, ceska a slovenska neurologie a neurochirurgie, vol.72/105 (1), pages 38¿44 (czech republic).The aim of this prospective study is to compare clinical results and radiological findings after the use of titanium and peek implants in stand-alone alif indicated for degenerative diseases of the lumbosacral spine.Between october 2005 to march 2007, a total of 28 patients (11 male and 17 female) with an average age of 46.71 years were included in the study.Surgery was performed using synframe dilator (synthes, usa) and either a peek implant visios (synthes, usa) in 14 patients or titanium implant syncage (synthes, usa) in another 14 patients.The follow-up period was at least 12 months.The following complications were reported as follows: 2 patients after l4/5 area surgery reported transient post-sympathectomy changes, in particular reduced sweating of the lower limb.1 patient has a general weakening of the abdominal wall, without the evidence of an incisional hernia.Visios group: 6 patients, despite initial relief lasting 2-3 months, experienced a recurrence of nerve root problems of the same intensity as before surgery.These patients were indicated for additional surgical stabilization one year after stand-alone alif surgery.All of these patients had modic type 1 changes on mri, and five of them had signs of bone cysts on their ct scans.A (b)(6) year old male patient had bone cystic changes 12 months after surgery.A (b)(6) year old male patient had bone cystic changes 12 months after surgery.A (b)(6) year old female patient had bone cystic changes and modic changes from type 2 to type 1 12 months after surgery.A (b)(6) year old female patient had bone cystic changes 12 months after surgery.A (b)(6) year old male patient had modic changes from 0 to type 1 12 months after surgery.A (b)(6) year old female patient had bone cystic changes and modic changes from type 2 to type 1 12 months after surgery.A (b)(6) year old female patient had modic changes from 0 to type 2 12 months after surgery.A (b)(6) year old female patient had bone cystic changes and modic changes from type 2 to type 1 12 months after surgery.A (b)(6) year old female patient had bone cystic changes 12 months after surgery.A (b)(6) year old female patient had modic changes from type 1 to type 2 12 months after surgery.A (b)(6) year old female patient had bone cystic changes 12 months after surgery.A (b)(6) year old male patient had modic changes from type 0 to type 1 12 months after surgery.Syncage group: in 2 patients, the nerve root irritation was subsided partially.A (b)(6) year old male patient had modic changes from type 1 to type 2 12 months after surgery.A (b)(6) year old female patient had modic changes from type 1 to type 2 12 months after surgery.A (b)(6) year old female patient had modic changes from type 0 to type 2 12 months after surgery.A (b)(6) year old female patient had modic changes from type 1 to type 2 12 months after surgery.This report is for an unknown synthes syncage.It captures the reported events of transient post-sympathectomy changes, in particular reduced sweating of the lower limb; general weakening of the abdominal wall and nerve root irritation was subsided partially.This is report 2 of 8 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS: SYNCAGE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 10871801
• MDR Text Key: 218507073
• Report Number: 8030965-2020-09096
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• 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