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

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

Patient Problems Failure of Implant (1924); Pain (1994); Physical Asymmetry (4573)

Event Date 08/29/2022

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: mathkour, m.Et al (2022), single level spondylolisthesis associated sagittal plane imbalance corrected by pre-psoas interbody fusion using anterior column release with 30 degrees expandable hyperlordotic cage, medicina, vol.58 (1172), pages 1-12 (usa) this study reports a 71-year-old female patient with grade ii l4-5 degenerative anterolisthesis with severe spinal stenosis and sagittal plane imbalance.A static titanium spacer with 8 degrees of lordosis was used, conduit¿, depuy synthes (raynham, ma, usa).The patient¿s baseline numeric rating scale (nrs) and oswestry disability index (odi) were 8 and 29, respectively.Three months after surgery her nrs decreased to 2 and her odi increased to 40.Pre-operative sagittal balance parameters were lumbar lordosis (ll) 57.4 degrees, sagittal vertical axis (sva) 79 mm, and pelvic incidence-lumbar lordosis (pi-ll) 6 degrees.Post-operatively improvement of the ll 62 degrees and pi-ll 2 degrees but worsening of the sva 120 mm was found.This report is for an unknown depuy spine spacer conduit a copy of the literature article is being submitted with this medwatch.This report is for one (1) unk - cage/spacer: conduit.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Investigation summary: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.Additional narrative: 510k: this report is for an unk - cage/spacer: conduit/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: UNK - CAGE/SPACER: CONDUIT
• 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 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 16787909
• MDR Text Key: 313750005
• Report Number: 8030965-2023-05036
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 04/21/2023
• 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: 04/03/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Female