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U.S. Department of Health and Human Services

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

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OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Injury (2348); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown locking compression plate/unknown lot.Part and lot number 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
This report is being filed after the review of the following journal article: n.Schwarz, m.Windisch, and b.Mayr (2009).Minimally invasive anterior plate osteosynthesis in humeral shaft fractures.European journal of trauma and emergency surgery page 271-276.(austria).This article presents the authors' experience with minimally invasive anterior plate osteosynthesis in a clinical observation study.A series of 12 patients with fractures of the humerus were treated with anterior minimally invasive plate osteosynthesis.The ages of the patients varied from 46 to 84.According to the ao classification, there were types a, b, and c shaft fractures.The largest homogeneous group was of five patients with type c1 fractures.One fracture was located in the subcapital region with extension into the shaft.With this fracture, there were a total of three fractures located at the proximal third of the humeral shaft.Five fractures were in the proximal and the intermediate third; one in the intermediate and the distal third; and three fractures were in the intermediate third only.Four different types of plates were used for fixation (all by synthes, bettlach, switzerland): philos long plate in six patients; locking compression plate (lcp) 3.5 in three patients; lcp 4.5 in two patients; and tibial metaphyseal plate 3.5/4.5/5.0 in one patient.The clinical results were assessed after six months or more post-operation in nine of the patients.One patient moved away and did not return for follow-up.The following complications were reported: patient 1 - (b)(6) year-old female patient implanted with philos had screw breakage at seven (7) months follow-up.Patient 3 - (b)(6) year-old female patient implanted with philos had non-union at ten (10) months follow-up.This patient also had pseudoarthrosis.After four weeks one distal screw broke and the other two were displaced.A revision with a philos osteosynthesis was not successful.The fracture only finally united upon performing a compression plate osteosynthesis and bone grafting.Patient 12 - (b)(6) year-old female patient implanted with lcp 4.5 had impingement at sixteen (16) months follow-up.The plate caused impingement symptoms due to the proximal position of the plate.The plate was removed after fracture healing, which improved her complaints.This report is for an unknown synthes locking compression plate.This is report 4 of 4 for (b)(4).
 
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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 Key8362598
MDR Text Key136894123
Report Number8030965-2019-61313
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Physician
Type of Report Initial
Report Date 01/30/2019
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 01/30/2019
Initial Date FDA Received02/22/2019
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;
Patient Age53 YR
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