MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

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

Patient Problem Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown cage/spacers.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown cage/spacers.Pma/510(k) number is not available.Product was not returned.Device history records review could not be completed without lot number.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: weng, h.Et al (2015), single-level anterior corpectomy with fusion versus 2-level anterior cervical decompression with fusion: a prospective controlled study with 2-year follow-up using cages for fusion, annals academy of medicine, vol.44, no.3, pages 188-190 (singapore).The aim of this study was to standardise the use of cages for both accf and acdf to compare the 2-year results and complications between these 2 surgical methods.Between 2007 to 2009, a total of 28 patients (24 male and 4 female) were included in this study.These patients were divided into 2 groups, the first group were treated with anterior cervical corpectomy and fusion (accf) which consist of 14 patients (12 male and 2 female) with a mean age of 58.5 years.The other group were treated with anterior cervical discectomy and fusion (acdf) which consist of 14 patients (14 male and 2 female) with a mean age of 56.5 years.The range follow-up was between 24 months to 40 months with a mean range of 26.8 months.The following complications were reported as follows: for accf group: 1 patient had residual c8 dermatomal numbness.3 patients had screw loosening resulting in migration and cutout.1 patient had a screw inserted into the disc space.1 patient had persistent neck pain.For acdf group: 1 patient had residual numbness.This report is for unknown cage/spacers.It captures the following adverse events: 1 patient had residual numbness.This is report 6 of 7 for (b)(4).

• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8631730
• MDR Text Key: 145767478
• Report Number: 8030965-2019-64317
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• 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: 04/23/2019
• 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