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

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: plates/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.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.(b)(4).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

Device report from synthes reports an event in netherlands as follows: this report is being filed after the review of the following journal article: duivenvoorden, t., et al.(2017), adverse events and survival after closing and opening wedge high tibial osteotomy: a comparative study of 412 patients, knee surgery, sports traumatology, arthroscopy, vol 25, pages 895-901 (netherlands).The purpose of this study was to examine the adverse event (ae) rate and survival rate of a consecutive series of 412 patients undergoing closing-wedge (cw) or opening-wedge (ow) high tibial osteotomy (hto).From 1993 to 2012, a total of 412 patients were included in the study.354 osteotomies were closing-wedge (cw) and 112 osteotomies were opening-wedge (ow) high tibial osteotomy (hto).Cw group's implants used staples (stryker, schönkirchen, germany), tomofix plate (synthes gmbh, oberdorf, switzerland) and puddu plate (arthrex, naples, florida).Ow-hto group's implant used either a puddu plate without plate locking screws (until 2006) or tomofix plate (from 2006 until now).The article did not specify which of the devices were being used to capture the following complications: 34 patients were deceased.73/354 non-survivors in the cw-group.8/112 non-survivors in the ow-group.Cw group.12 patients had a non-union.Serous adverse event.14 patients had sensory palsy of the common peroneal nerve.1 patient had motor palsy of the common peroneal nerve.8 patients had pseudoarthrosis.6 patients had wound infection treated with antibiotics.2 patients had fracture of the tibial plateau.7 patients had re-hto.Re-hto was performed because of overcorrection or undercorrection or loss of correction.1 patient had delayed union.1 patient had lesion of the anterior tibial artery.2 patients had deep venous thrombosis.2 patients had infection of the urinary tract.1 patient had post-surgery diffuse lung emphysema.1 patient had compartment syndrome.169 patients had hardware removal.Ten hardware removals in the closing-wedge group were performed prior to total knee arthroplasty.1 patient had malposition of hardware.Adverse event.1 patient had wound infection without antibiotic treatment.1 patient had complex regional pain syndrome.73 osteotomies have been reviesd to uka or tka.Ow group.4 patients had a non-union.Serous adverse event.4 patients had pseudoarthrosis.5 patients had wound infection treated with antibiotics.2 patients had fracture of the tibial plateau.3 patients had re-hto.Re-hto was performed because of overcorrection or undercorrection or loss of correction.1 patient had pulmonary embolus.1 patient had infection of the urinary tract.1 patient had compartment syndrome.79 patients had hardware removal.Two hardware removals in the opening-wedge group were performed prior to total knee arthroplasty.Adverse event.11 patient had iliac crest pain.56 patients of the opening-wedge group underwent spongioplasty with autologous bone harvested at the iliac crest.Of these patients, 11 patients reported pain at the iliac crest for more than 6 weeks 2 patients had wound infection without antibiotic treatment.1 patient had complex regional pain syndrome.8 osteotomies have been reviesd to uka or tka.This report is for an unknown synthes tomofix plate (synthes gmbh, oberdorf, switzerland).This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• 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: 10363040
• MDR Text Key: 209157046
• Report Number: 8030965-2020-05605
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/04/2020
• 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