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

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

Patient Problems Purulent Discharge (1812); Necrosis (1971); Swelling (2091); No Code Available (3191)

Event Date 04/20/2005

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown universal spinal system (uss)/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: hahn, f., zbinden, r., min, k.(2005), late implant infections caused by propionibacterium acnes in scoliosis surgery, european spine journal, vol.14, no.8, pages 783-788 (switzerland).The aim of this retrospective study is to evaluate the incidence of late infections, to identify the causative bacteria in our series compared with other studies, to analyze the success of management with implant removal and systemic antibiotic therapy, and to evaluate the loss of scoliosis correction after implant removal.Between 1995 and 2002, a total of 101 patients (33 male and 69 female) with a median age 13.6 (6-19.5) years at operation, were reviewed for incidence of infection.The spine was instrumented in the thoracic as well as the lumbar region with pedicle screw-only constructs using stainless steel implants - universal spinal system.The minimum postoperative follow-up time was 24 months (maximum 106 months, mean 57).The following complications were reported as follows: 7 patients were diagnosed with late infection with surgical site swelling and experienced 2-8 weeks of pain postoperatively.These patients underwent revision surgery.Microscopic purulence at the implant site was observed.Necrotic tissue around the implant site was observed.One patient had a single broken screw and one patient had partial screw loosening distally.This report captures the reported 7 patients with a local swelling at the operation site, 2 with sinus drainage, 6 patients experienced a macroscopic purulence at the implant site and 1 patient had a necrotic tissue around the implant material.This report is for an unknown universal spinal system (uss).This is report 1 of 2 for (b)(4).

• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8493939
• MDR Text Key: 141308387
• Report Number: 8030965-2019-62578
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• 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: 03/18/2019
• 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