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 Abscess (1690); Hematoma (1884); Nerve Damage (1979); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown synthes spine locking 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.(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: koci¿, j.Et al (2004), injuries to the lower cervical spine, acta chirurgiae orthopaedicae et traumatologiae cechoslovaca, vol.71 (6), pages 366-372 (czech republic).The aim of this study is to show current trends in the diagnosis and treatment of this trauma.Between 1995 to 2003, a total of 363 patients (300 male and 63 female) were included in the study.Surgery was carried out in 263 patients using cervical spine locking plate (cslp) or other competitor's device in anterior approach group and cervifix or other competitor's device in posterior approach.The following complications were reported as follows: not specified group: 17 patients died.Anterior group: 9 patients had injury of recurring laryngeal nerve.2 patients who underwent anterior approach had failure of osteosynthesis, which necessitates reoperation.1 patient had an abscess in the operative wound following anterior approach.2 patients had hematoma of the anterior operation wound requiring revision surgery.1 patient had pseudoarthrosis and cslp fracture.Once the plate was removed, patient healed-up with no complications.1 patient had loosening of two anterior, bicortically inserted screws.Posterior group: 1 patient who underwent posterior approach had failure of osteosynthesis, which necessitates reoperation.This is report 2 of 7 for (b)(4).This report is for unknown synthes spine locking 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: 8929879
• MDR Text Key: 155495086
• Report Number: 8030965-2019-67696
• 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: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• 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: 08/13/2019
• 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