MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

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

Patient Problems Reaction (2414); No Code Available (3191)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screws: trauma/unknown lot.Part and lot numbers are unknown; udi 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.

Event Description

This report is being filed after the review of the following journal article: lee s., han s., yoo b., kim j., (2019)outcomes of locking plate fixation with fibular allograft augmentation for proximal humeral fractures in osteoporotic patients comparison with locking plate fixation alone,the bone joint journal, volume 101-b, pages 260¿265 (korea, south) doi: 10.1302/0301-620x.101b3.Bjj-2018-0802.R1.This study aims to compare and analyze the clinical and radiological outcomes of using a locking plate in the management of a displaced proximal humeral fracture with and without an associated fibular allograft.Between 2007 and 2016, 112 consecutive patients with a proximal humeral fracture were surgically treated.Between 2007 and 2012, 61 patients underwent locking plate fixation only (lp group) 52 patients (14 males, 38 females) mean age 73.3 (range 52 to 89) of these were evaluated.Between 2013 and 2016, 51 patients underwent locking plate fixation with an associated fibular strut allograft (fa group) 45 patients (12 males, 33 females) mean age 75.6 years (range 55 to 87)of these were evaluated.A 3.5 mm proximal humeral locking plate (philos; depuy synthes, paoli, pennsylvania) was used in all patients.Mean follow-for lp group 14.2 mths (12 to 19 range) while for fa group is 2.6 mths (12 to 17 range).The following complications were reported as follows: four patients had varus malalignment and two had changes in hhh that were > 3 mm.One patient in the fa group developed osteonecrosis (fig.3).He had minor symptoms that responded to conservative treatment.There was failure of fixation in one patient in the lp group (fig.2).There was penetration of a screw in four patients and loosening of a screw in one.A screw was removed in four and left in situ in one due to his general condition there was penetration of a screw in four patients and loosening of a screw in one.One screw was left in situ in one due to his general condition.This report is for an unknown synthes 3.5 mm proximal humeral locking plate.This report is for one (1) unk - screws: trauma.This is report 8 of 10 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10789211
• MDR Text Key: 217100350
• Report Number: 8030965-2020-08602
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2020

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: 10/09/2020
• Initial Date FDA Received: 11/04/2020
• 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