MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problems Perforation of Vessels (2135); Blood Loss (2597)

Event Date 04/17/2010

Event Type  Injury  

Manufacturer Narrative

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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: elmiligui, y., koptan, w., and emran, i.(2010), transpedicular screw fixation for type ii hangman¿s fracture: a motion preserving procedure, european spine journal, vol.19 (issue 8), pages 1299-1305 (egypt).The aim of this prospective, non-randomized multicentre study is to evaluate the results of c2 transpedicular fixation in type ii tsa including clinical outcome, x-ray and ct evaluation of fracture reduction, union and accuracy of screw placement.Between 2000 to 2007, a total of 15 patients (9 male and 6 female) with a mean age of 37 years (range, 22-61 years) were included in the study.Surgery was performed using a standard ao 3.5 mm cortical screw or 4 mm cancellous screw.All patients were viewed at 6 weeks, 12 weeks, 36 weeks and 1 year postoperatively and were later followed up at yearly intervals.Clinical evaluation and plain x-rays were performed at each visit; at 6-month follow-up, additional dynamic lateral flexion/extension views and a ct scan were performed.The average follow-up period was 32 months (range 25-56 months).The following complications were reported as follows: two pedicle screws (6.6%) showed minimal (defined as <2 mm) intrusion; one into the spinal canal and the other into the vertebral foreamen.1 patient had severe bleeding during the drilling of one of the screws which was presumed to be due to a vertebral artery/ vein injury.Postoperatively, ct scan confirmed the malpositioned screw to be minimally intruding the foramen¿nevertheless, no further intervention was required.This report is for an unknown synthes screws.This is 2 of 2 for report (b)(4).

• Brand Name: UNK - SCREWS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; west chester, PA 19380 ; 6107195000
• MDR Report Key: 9244534
• MDR Text Key: 175870838
• Report Number: 8030965-2019-69726
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2019
• 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