• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; REAMER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OBERDORF SYNTHES PRODUKTIONS GMBH; REAMER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Injury (2348); Non-union Bone Fracture (2369); No Code Available (3191)
Event Date 07/25/2017
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown reamer-irrigator-aspirator (ria) device/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: metsemakers wj.Et al (2019), reamer¿irrigator¿aspirator bone graft harvesting for treatment of segmental bone loss: analysis of defect volume as independent risk factor for failure, european journal of trauma and emergency surgery, volume 45, pages 21-29, (belgium).The purpose of this study was to conduct a retrospective evaluation of our results with the treatment of segmental bone loss using ria-harvested autologous bone graft.Furthermore, different risk factors for failure of this technique were analyzed.Between june 2008 and march 2015, 72 skeletally mature patients with segmental bone loss due to acute trauma (defect fractures) or non-union (septic/aseptic), who were treated with a bone graft that was harvested using the ria technique were included in the study.There were 49 male and 23 female patients with a mean age of 45.4 years (range, 18-78 years).40 patients underwent a one-stage procedure, 32 patients underwent ria bone graft harvesting in the context of a two-stage procedure (i.E., masquelet technique).In 4 of these cases, ria autologous bone graft material was augmented with an unknown bone morphogenetic protein (bmp)-7 and unknown beta-tricalcium phosphate (tcp).All procedures were performed using an unknown synthes reamer-irrigator-aspirator device.At the time of ria bone graft harvesting, 40 patients had a plate osteosynthesis in situ, 25 a nail osteosynthesis and in 7 patients a combination of both implants were used.All patients were evaluated using post-operative conventional x-ray series that were consistently included in the follow-up.Complications were reported as follows: 33 patients showed no signs of bone healing (non-union) and needed revision surgeries (i.E., distraction osteogenesis, free vascularized fibula grafting or amputation).3 patients had a deep infection at the grafting site after the treatment using ria.These patients had no infection prior to the procedure.2 patients had a proximal femoral fracture after reaming using the ria technique, necessitating surgical treatment using a proximal femoral nail.3 patients showed anterior cortex perforation during the operation (distally) and were treated conservatively.This report is for one (1) device- unknown synthes reamer-irrigator-aspirator (ria) device.This is report 1 of 1 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
REAMER
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 Key8667551
MDR Text Key146961055
Report Number8030965-2019-64875
Device Sequence Number1
Product Code HTO
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
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 05/07/2019
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 05/07/2019
Initial Date FDA Received06/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-