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

Catalog Number UNK - CAGE/SPACERS: ORACLE

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Without a valid lot number the device history records review could not be completed.This report is for one (1) unknown/unk - cage/spacers: oracle.Part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Complainant device is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: cheung, m.Y.And cheung, p.(2020), oblique lumbar interbody fusion in management of lumbar degenerative spinal stenosis in chinese population, journal of orthopedics, trauma and rehabilitation, vol.27(2), pages 119¿127 (hong kong).The purpose of this study was to assess the outcomes of a cohort of local chinese patients who underwent oblique lumbar interbody fusion (olif) surgery for lumbar degenerative diseases.Between january 2016 and december 2018, a total of 60 patients underwent olif surgery at 83 surgical levels.There were 17 men and 43 women, with ages ranging from 35 years to 83 years (mean age 68.4 years).Implants used were medtronic clydesdale olif 25 cages, nuvasive coroent xl/xlw cages, and synthes oracle cages.The article did not specify which of the devices were being used to capture the following complications: cage subsidence was noted in 10 levels, ranging from 2 mm to 7 mm, with 4.4 mm subsidence on average.Fusion at 6 months was failed at l4/5 level in a patient undergoing olif surgery on two levels.It was associated with loss of reduction of retrolisthesis, yet neurological symptoms of this particular patient still improved as direct posterior decompression was performed.Follow-up ct scans of this patient at post-operative 8 months showed successful fusion with no further loss of reduction.Among the 68 operated levels with spondylolisthesis, complete reduction of slip was achieved in 38 levels, while partial reduction was achieved in 26 levels, including two levels with grade 2 slips reduced to grade 1 slips this report is for an unknown synthes oracle cage this report is for one (1) unk - cage/spacers: oracle this report is 2 of 2 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS: ORACLE
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west cheser, PA
• MDR Report Key: 11838070
• MDR Text Key: 265580730
• Report Number: 8030965-2021-03992
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CAGE/SPACERS: ORACLE
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention