MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

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

Patient Problems Unspecified Infection (1930); Irritation (1941); No Consequences Or Impact To Patient (2199); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown synthes plates/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: hulsmans mhj et al (2016).Anteroinferior versus superior plating of clavicular fractures.Journal of shoulder and elbow surgery.Volume 25.Page 448-454.(the netherlands).The aim of the present study was to determine the optimal plate position comparing implant-related irritation and the proportion of plate removal in patients with clavicular fractures undergoing plate fixation by an anteroinferior approach or a superior approach.Between november 2008 and june 2013, a total of 99 patients with displaced midshaft clavicular fractures who underwent open reduction and plate fixation and have completed follow-up were included in the study.Patients were divided into 2 groups.The group with anteroinferior plate fixation consisted of 39 patients (36 men and 3 women with a mean age of 40.3 +/- 11.5 years) and they were implanted with an unknown synthes variable angle-locking compression plate (va-lcp) anterior clavicular plate with a minimum of 4 unknown synthes screws on each side of the fracture.The group with superior plate fixation consisted of 60 patients (55 men and 5 women with a mean age of 38.6 +/-14.6 years) and they were implanted with an unknown synthes plate positioned and fixed on the anterosuperior surface of the clavicle starting medially using unknown nonlocking synthes screws.Patients were followed up until the implant was removed or, if the implant was still in place until they were contacted in june 2014.The primary outcome parameter was implant-related irritation.Complications were reported as follows: (anteroinferior plating group): 3 patients had an infection and were treated with antibiotics.4 patients had irritation but implant removal was not necessary.2 patients had irritation and have considered implant removal.1 patient had the implant removed by request without experiencing irritation.14 patients had implants removed due to implant-related soft tissue irritation.1 patient had implant breakage and underwent revision with bone graft.(superior plating group): 3 patients had an infection and were treated with antibiotics.1 patient had nonunion and underwent revision with bone graft.12 patients had irritation but implant removal was not necessary.3 patients had irritation but did not request for removal due to fear of reoperation 4 patients had irritation and have considered implant removal.6 patients had the implant removed by request without experiencing irritation.22 patients had implants removed due to implant-related soft tissue irritation.1 patient had implant breakage and underwent revision with bone graft.This report captures the following adverse events: infection, nonunion, revised, implant irritation, implant-related soft tissue irritation, implant removed.This report is for unknown synthes plates.This is report 4 of 6 for (b)(4).

• Type of Device: PLATE, FIXATION, BONE
• 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: 8265358
• MDR Text Key: 133835726
• Report Number: 8030965-2019-60137
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/21/2019
• 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