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

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).

• 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: 8362598
• MDR Text Key: 136894123
• Report Number: 8030965-2019-61313
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• 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 Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR