MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem No Apparent Adverse Event (3189)

Patient Problems Incontinence (1928); Neurological Deficit/Dysfunction (1982); Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes universal spinal system (uss)./unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: xie, q.Et al (2002), application of uss screw-rods system in the reconstruction of the stability of the lumbar-sacrum after resection of sacrum tumor, chinese journal of clinical rehabilitation, vol 6(6), pages 909-910 (china).The aim of this article is to introduce one operation method applied with uss (universal spine system) screw-rods system for the reconstruction of the stability of the lumbar-sacrum after resection of sacrum and tumor and discuss indications and feasibility of the operation method.A total of 5 patients (4 males and 1 female) with the mean age of 50 years (range 34-60) were included in this study.The patients had a resection of the whole vertebral plane and tumor were performed by posterior median incision or posterior-shaped incision using unknown synthes metal rods, pedicle screws and a transverse links system.The duration of the follow up was 1-12 months.The following complications were reported as follows: 2 patients had occurence of urinary and fecal incontinence and sensory disturbance in the perineum.1 patient had sensory disturbance 2 weeks after the operation.2 patients had sensory partial decrement of perineum but was restored to normal after 2 weeks.This report is for an unknown synthes screw-rods system.This is report 1 of 1 for (b)(4).

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.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.

• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8544024
• MDR Text Key: 142919919
• Report Number: 8030965-2019-63113
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention