MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

Device Problem Device Slipped (1584)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screws: trauma/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.

Event Description

This report is being filed after the review of the following journal article: liska f., et al (2018) smoking and obesity influence the risk of nonunion in lateral opening wedge, closing wedge and torsional distal femoral osteotomies, knee surg sports traumatol arthrosc volume 26, pages 2551¿2557 (germany).This retrospective study aims to evaluate the effect of general risk factors like smoking habits and obesity on the nonunion rate in lowdfo and lateral closing wedge dfo (lcwdfo).Between 2008 and 2016, all consecutive lateral dfo that were performed were assessed for the present study.One-hundred and fifty lateral dfo could be included in this study.The patients were divided into two groups: the lowdfo group consisted of 98 cases (57 females, 41 males) age 32.1 years and the lcwdfo group consisted of 52 cases (19 females, 33 males) age 46.3 years.For internal fixation, the tomofix distal femoral plate (depuy synthes, umkirch, germany) was used in 94 osteotomies, and a peekpower plate (carbon-fibre reinforced polyether ether ketone (peek) arthrex, germany) was used in 4 patients.The median time until plate removal was 1.2 years (iqr 1.0¿1.5).Patients whose plate removal was not performed at the institution were invited for a clinical follow-up or were interrogated by phone about their medical course.The following complications were reported as follows: a case of a (b)(6) female who underwent lowdfo developed a nonunion and required revision surgery.Revision was performed with plate exchange and transplantation of autologous bone graft from the iliac crest.(1 of the 5 patients in lowdfo group that showed asymptomatic delayed union where revision is necessary) a case of a (b)(6) female who underwent lowdfo developed a nonunion and required revision surgery.Revision was performed with plate exchange and transplantation of autologous bone graft from the iliac crest.(1 of the 5 patients in lowdfo group that showed asymptomatic delayed union where revision is necessary) a case of a (b)(6) female who underwent lcwdfo developed a nonunion and required revision surgery.A case of a (b)(6) female who underwent lcwdfo developed a nonunion and required revision surgery.A case of a (b)(6) male who underwent lcwdfo developed a nonunion and required revision surgery.A case of a (b)(6) male who underwent lcwdfo developed a nonunion and required revision surgery.A case of a (b)(6) female who underwent lcwdfo developed a nonunion and required revision surgery.In the lowdfo group, five patients showed an asymptomatic delayed union, eventually healing in the course 14¿16 months.A radiograph showing a biplane lowdfo in a.-p.View; an interruption of the medial cortex is evident (white arrow).Same patient after 7 months.Although the medial cortex healed, a nonunion occurred in the lateral aspect.Hinge alterations that occurred intraoperatively, as well as any slightest interruption of the medial cortex on follow-up radiographs, were seen in 13 osteotomies.In addition to correction in frontal plane, in 28 cases, a supplementary torsional osteotomy was performed.In these cases, the surgical external de-rotation ranged from 5° to 20 degrees.In the lcwdfo group, two delayed unions occurred without pain or limitation in weight bearing and eventually plate removal after 15 and 24 months.Intra- and post-operative complications in 150 cases 4 impaired wounds, 3 arthrofibrosis, 3 deep infection, 1 bleeding, 1 wound granuloma, 1 sural nerve lesion, delayed union: 5 open wedge ot, 2 closed wedge ot, nonunion: 2 open wedge ot, 5 closed wedge ot, 1 overcorrection treated with revision.2 screw loosening, treatment : 1 screw removal.This report is for an unknown synthes tomofix distal femoral plate distal femoral plate.This report is for one (1) unk, screws: trauma.This is report 10 of 10 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,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 19280 ; 6103142063
• MDR Report Key: 10421023
• MDR Text Key: 210588969
• Report Number: 8030965-2020-06091
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/18/2020
• 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