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

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

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: hey, h.W.D., lau, p.H.B., hong, c.C.A., and hee, h.T.(2012), post-laminectomy spondylolisthesis - a review of the posterior elements and their contribution to the stability of the lumbar spine, the open spine journal, vol.4 (xx), pages 5-9, (singapore).The aim of this study is to present a review of the posterior elements and their contribution to the stability of the lumbar spine post-laminectomy spondylolisthesis.Between 2005 to 2010, a total of 20 patients (4 male and 16 female) with a mean age of 66.5 years (range 52 to 82 years) were included in the study.Patients underwent transforaminal lumbar interbody fusion.Implants used included pedicle screws such as expedium (depuy spine, raynham, ma) in 8 patients, moss miami (depuy spine, raynham, ma) in 3 patients, viper (depuy spine, raynham, ma) in 2 patients, and competitor in 7 patients.Cages were also used e.G., concorde (depuy spine, raynham, ma) in 9 patients, harm¿s (depuy spine, raynham, ma) in 3 patients, leopard (depuy spine, raynham, ma) in 2 patients, and competitor in 6 patients.The mean follow-up period was unknown.The following complications were reported: 2 patients had inadvertent intra-operative dura tear that was primarily repaired without any further complications.This report is for an unknown depuy spine expedium, unknown depuy spine moss miami, unknown depuy spine viper, unknown depuy spine concorde cage, unknown depuy spine harm¿s cage, and unknown depuy spine leopard cage.This report is for (1) unknown cage/spacer.This report is 4 of 6 for (b)(4).

• Brand Name: UNKNOWN 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12058208
• MDR Text Key: 264042759
• Report Number: 1526439-2021-01278
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/24/2021
• 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