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

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for one (1) unknown screw.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown screw.Pma/510(k) number is not available.(b)(4).Product was not returned.Based on the information available, it has been determined that no corrective and 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: korkmaz m.Et al (2008), the results of internal fixation of proximal humeral fractures with the philos locking plate, acta orthop traumatol turc, pages 97-105 (turkey).The objective of this study was to evaluate the results of patients treated with the philos (proximal humeral internal locking system) locking plate.Between september 2005 and december 2007, a total of forty-one patients who has proximal humeral fractures were evaluated in two age groups.Fractures were treated with the philos plate.Reduction was attained by passing ethibond sutures.Patients were divided into two groups; patients who were below the age of 65 (group a) and patients with the age of 65 and above (group b).Group a consists 24 patients (12 males, 12 females; mean age 47 years; range 24 to 64 years) younger than 65 years, and group b involved 17 patients (4 males, 13 females; mean age 78 years; range 67 to 90 years) at or above 65 years.All fractures were classified according to the ao/asif system radiographically.Surgery was performed with the deltopectoral approach in 10 and two patients, and with a deltoid split in 14 and 15 patients in group a and b, respectively.Functional and radiographic results were evaluated after a mean follow-up of 15 months (range 6 to 28 months).The following complications were reported as follows: (b)(6) female patient had intra-articular screw penetration and the screws that entered the joint were replaced by a deltoid split intervention after five months, and the defect in the head fragment was grafted with allograft as seen in figure 4.(b)(6) female patient had a displacement of the greater tuberculum as seen in figure 5.(b)(6) male patient experienced displacement of the tuberculum majus and the head was located on the varus and the plate was placed obliquely as seen in figure 6.4 patients had insufficient reduction.3 patients had varus displacement of the humeral head as seen in figure 7.This report is for an unknown synthes locking screws.This is report 5 of 7 for (b)(4).

• Type of Device: SCREW,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: 8206610
• MDR Text Key: 131788616
• Report Number: 8030965-2018-59335
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2018
• 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: 62 YR