MAUDE Adverse Event Report: SYNTHES GMBH UNK - RESORBABLE IMPLANTS: PLATES; PLATE,FIXATION,BONE

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

Patient Problems Inflammation (1932); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown resorbable implants: plates/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.

Event Description

This report is being filed after the review of the following journal article kilipiris e., horn f., fesenko i., (2020) the value of resorbable osteosynthesis in reconstructive surgery of craniosynostosis: a comparative study between absorbable sutures and a resorbable plating system, childs nerv syst volume 36, page 2178 (ukraine).This study aims to compare and evaluate the effectiveness of absorbable sutures and a resorbable plating system as a fixation method in the treatment of craniosynostosis without modification of the osteotomy design.A total of 100 children with age up to 24 months, the mean age at the time of surgery was 8.5 and 8.7 months respectively in the two groups, were investigated.Children were divided into two groups (50 patients each), according to the type of fixation material used: in the first group vicryl sutures (ethicon slovakia) were used for osteosynthesis, and in the second group the rapidsorb plating system (synthes cmf slovakia) was applied.The average follow-up period was 36,8 months in the first group and 36,9 months in the second group.The following complications were reported as follows: in the second group one patient developed a wound infection, and another one displayed signs of inflammatory skin reaction.This report is for an unknown synthes rapidsorb plating system.

Event Description

Device report from synthes reports an event in (b)(6).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: UNK - RESORBABLE IMPLANTS: PLATES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11832937
• MDR Text Key: 250888972
• Report Number: 8030965-2021-03975
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

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
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 05/17/2021
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 05/27/2021
• Patient Sequence Number: 1