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 Calcium Deposits/Calcification (1758); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown spine screws/unknown lot.Part and lot numbers are unknown; udi 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: ¿tulík, j., krbec, m.And vyskocil, t.(2003), injury to the lower cervical spine: monocortical stabilization technique, acta chirurgiae orthopaedicae et traumatologiae cechoslovaca, vol.70, pages 226-232 (czech republic).The aim of this study is to evaluate a set of patients with lower cervical spine injury treated with the synthes cslp monocortical system.Between january 1994 to august 2002, a total of 68 patients (49 male and 19 female) with mean age of 37.6 years (12 to 79 years of age) were included in the study.Surgery was performed using cslp system (synthes) with monocortical screws 14 mm long; additional fixation using hook plates or a cervifix fixator (synthes) for locked dislocation or severe instability.The follow-up period was 6 to 105 weeks after the primary surgery, with average 31.4 months.The following complications were reported as follows: 5 patients experienced occasional pain in the cervical spine area, while 1 patient experienced such pain continuously.17 patients had mild limitation of motion (75¿90% of the normal range) and 7 patients had a more pronounced limitation (50¿75 %).19 patients had neurological deficit.13 of which experienced improvement while 6 patients remained unchanged.2 patients had calcification of the anterior longitudinal ligament as a manifestation of adjacent segments irritation at the earliest after 6 months, 6 patients after 1 year, and 11 patients at the final evaluation.4 patients had profuse bleeding from the spinal canal that needs to be stanched.1 patient had instrumentation failure, where cranial screws broke in a one-segment c5¿6 fixation 12 months after the primary surgery.Revision revealed solid bone tissue fusion of the segment; the plate and two screws were extracted and left the two broken screws in place.This is report 4 of 7 for (b)(4).This report is for unknown synthes spine screws.

• 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 ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9115544
• MDR Text Key: 164418968
• Report Number: 8030965-2019-68652
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• 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: 08/29/2019
• 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