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

Catalog Number UNK - CAGE/SPACERS

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

Patient Problem Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown cage/spacer/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.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

Device report from synthes reports an event in china as follows: this report is being filed after the review of the following journal article: wang f, et al.(2019), effect of l5 ~ s1 fusion on lumbar sagittal parameters and adjacent degeneration, journal of nanjing medical university, volume 39, number 07, pages 1028-1033, (china).The objective of this study is to study the effect of l5 ~ s1 fusion on lumbar sagittal parameters and adjacent degeneration.From september 2013 to june 2015, 34 patients with l5 ~ s1 disc herniation who received l5 ~ s1 fusion were selected as study group and 120 patients who received simple l5 ~ s1 disc herniation resection as control group for retrospective study.There were 81 males and 73 females with mean age of (45.69 ± 9.51) years.The patients in the study group underwent transforaminal fusion and internal fixation and were implanted with an unknown synthes fusion cage filled with the appropriate height of the broken bone block.Postoperatively, patients were to avoid heavy physical work and bending over to move heavy objects within a month.The mean follow-up duration of 23.65 months (22-25 months).The complications were reported as follows: 3 patients had adjacent segment degeneration 3 months after operation.10 patients had adjacent segment degeneration occurred in the second year.16 patients had adjacent segment degeneration occurred in the second year after surgery.This report is for the unknown synthes fusion cage.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - CAGE/SPACERS
• 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 ; 6103142063
• MDR Report Key: 15044926
• MDR Text Key: 296089979
• Report Number: 8030965-2022-04939
• 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
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CAGE/SPACERS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• 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