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

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes lcp/ liss system; unknown plate/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 yolanda hernanz gonzalez, andres diaz martin, fernando jara sanchez, and carlos resines erasun (2007), early results with the new internal fixator systems lcp and liss : a prospective study, acta orthopaedica belgica vol.73(1), pages 60-69, (spain).The aim of this study was to investigate the results of an initial application of the lcp and liss across a wide range of indications and to make conclusions relevant for routine clinical application.Between october 2002 and april 2005, a total of 112 patients (36 male and 76 female) with a mean age of 53.1 years (ranges, 21 ¿ 85 years) were included in the study.These patients had 121 injuries and were treated with a new lcp/ liss system synthes.The mean duration of follow-up was 20 months.The article did not specify which of the devices were being used to capture the following complications: 1 patient had delayed or non-union.(table 2).1 patients had superfacial infection.(table 2).1 patients had wound dehiscence.(table 2).9 patients had implant-related pain.(table 2).1 patient had bone grafting and change of implant after non-union.(table 3).2 patients had debridement after infection.(table 3).12 patients had implant removal.(table 3).1 patient had implant breakage.(table 2).1 patient had reoperation after plate breakage.(table 3).A (b)(6) year-old man had a broken plate and delayed union after nine months nad was treated successfully iwht removal of the broken plate and intramedullary nailing with an 11mm ctn with proximal and distal locking, in combination with autogenous cancellous bone graft.A (b)(6) year-old woman presented loosening of the implant and loss of reduction.She refused a revision operation.A (b)(6) year-old man presented wound dehiscence and superficial infection and the tibial plate was exposed.This is report 1 of 10 for (b)(4).This report is for an unknown synthes lcp/ liss system; unknown plate.

• Brand Name: UNK - PLATES
• 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: 9192550
• MDR Text Key: 173182668
• Report Number: 8030965-2019-69322
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 09/25/2019

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: 09/25/2019
• Initial Date FDA Received: 10/15/2019
• 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