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

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

Patient Problem Abscess (1690)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown synthes 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.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: stechow, dv., scale, d.And rauschmann, ma.Et al (2005), minimizing the surgical approach in patients with spondylitis, clinical orthopaedics and related research, no.439, pages 61-67 (germany).The purpose of this retrospective study is to determine whether infections could be cleared by treating patients with spondylitis with instrumentation and debridement of the spondylitic region by just a dorsal approach in combination with local antibiotic treatment.In 1999, a total of 16 patients (13 male and 3 female) with a range age of 38-85 years underwent dorsal approach.For instrumentation, the universal spine system (synthes, umkirch, germany was used in 2 patients.Further follow-up visits and radiographs were scheduled at 3, 6, and 12 months after surgery and annually thereafter.Patients were followed-up for a minimum of 12 and up to 48 months.The following complications were reported as follows: 2 patients with transpedicled filling showed a delayed fusion.2 patients had revision surgery because of seroma and persistent wound drainage during the first 10 days.2 patients died, 1 week after surgery from a fulminant thromboembolism in the lungs and 1 patient from a septic thromboembolism in the brain 4 weeks after surgery.A (b)(6) female underwent revision surgery and had seroma.A (b)(6) female had epidural abscess.An (b)(6) male had exitus letalis.A (b)(6) male had exitus letalis and septic cerebral embolization.A (b)(6) male underwent revision and had seroma.A (b)(6) male had respiratory insufficiency and temporal tetraparesis.A (b)(6) male had weakness psoas muscle.This report is for a (b)(6) female who had epidural abscess.This report is for an unknown synthes universal spinal system (uss).This is report 3 of 6 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: 8567202
• MDR Text Key: 143678224
• Report Number: 8030965-2019-63318
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• 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: 04/03/2019
• 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
• Patient Age: 79 YR