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

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

Patient Problems Tingling (2171); Non-union Bone Fracture (2369)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown synthes 3.5 mm locking compression plate (lcp) distal humerus plate (dhp)/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.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: biz, c.Et al (2017), the challenging surgical treatment of closed distal humerus fractures in elderly and octogenarian patients: radiographic and functional outcomes with a minimum follow up of 24 months, archives of orthopaedic and trauma surgery archives of orthopaedic and trauma surgery, vol.137(10), pages 1371-1383 ((b)(6)).The main purpose of this retrospective, non-randomized cohort case study is to evaluate the clinical and radiographic outcomes of dhfs with a minimum follow-up of 24 months in a consecutive series of patients older than 65 years operatively treated by open reduction and internal fixation (orif), using the locking compression plate (lcp) distal humerus plate (dhp) system.Secondly, to propose proper indications for orif for two elderly age ranges (pts <85 years, pts =85 years) and two fractures patterns groups (ao 13-b1-c2 vs 13-c3).Between january 2009 and june 2014, a total of 36 patients (16 male and 20 female) with a mean age of 80.3 years (range, 66-95 years) underwent open reduction and internal fixation (orif) using the locking compression plate (lcp) distal humerus plate (dhp) system (by depuy synthes, (b)(4)), consisting of a single or double anatomically pre-contoured 3.5 mm locking plate, depending on the fracture pattern.These patients were divided into two groups for each of the variables considered: age range groups (patients >65 years and <85 years and patients =85 years); ao fracture patterns groups (13-b1-c2 including: 13-b1, 13-b2, 13-c1 and 13-c2) and 13-c3.All patients underwent clinical and radiographic assessment with the same protocol before surgery, as well as at 1, 3 and 12 months, following the standard aftercare algorithm; then they were assessed at least 24 months after surgery according to the study protocol.The following complications were reported as follow: a (b)(6) female with 13-c3 fracture type had a humerus pseudoarthrosis and tingling at 31 months follow-up.This report is for an unknown synthes 3.5 mm locking compression plate (lcp) distal humerus plate (dhp).Additional parts for this complained event are captured on related complaints (b)(4).This is report 5 of 6 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8208523
• MDR Text Key: 131793279
• Report Number: 8030965-2019-59382
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• 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: 12/10/2018

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: 12/10/2018
• Initial Date FDA Received: 01/02/2019
• 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: 93 YR