MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK: CAGE/SPACER; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

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

Patient Problem Osteolysis (2377)

Event Date 03/31/2021

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 device/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: 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

This report is being filed after the review of the following journal article: hu a, et al.(2021), mid- and long-term outcomes of hybrid surgery combined dynesys fusion and non-fusion stabilization in the treatment of degenerative lumbar diseases, chin j orthop, vol.41, no.17, pages 1237-1247 (china).This objective of the study is to evaluate the mid- and long-term outcomes of dynesys hybrid surgery (in some segments act as a non-fusion device, in other segments act as an alternative of rigid fixation in combination with interbody fusion) in the treatment of multi-segmental lumbar degenerative disease.Between may 2011 to september 2016, 27 patients who received dynesys hybrid surgery (hybrid group) for the treatment of lumbar degenerative disease were included in the study.There were 8 males and 19 females with a mean age of 59.1±11.9 years (range 23-78 years).For this group, 32 segments received transforaminal lumbar interbody fusion with dynesys stabilization and were implanted with an unknown depuy spine intervertebral cage and a competitor¿s pedicle screws.35 segments received dynesys non-fusion stabilization and were implanted with competitor¿s fusion spacer and pedicle screws.During the same period, 27 patients who underwent conventional transforaminal lumbar interbody fusion with rigid internal fixation were included as the control group and were implanted with unknown devices.Patients of hybrid group and control group were followed up for an average of 83.8±20.9 months (48-112 months) and 87.3±16.2 months (53-114 months), respectively.Complications were reported as follows: (tlif with dynesys stabilization group only) 4 patients developed adjacent segment degeneration.This report is for an unk: cage/spacer.This is report 1 of 1 for (b)(4).

• Brand Name: UNK: CAGE/SPACER
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 15373181
• MDR Text Key: 299450918
• Report Number: 1526439-2022-01550
• 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: 09/07/2022
• 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: 08/15/2022
• 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): Other