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

Catalog Number UNK - PLATES: TRAUMA

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

Patient Problems Injury (2348); No Code Available (3191)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates/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: luciani p., et al (2020) angular stable plate versus reverse shoulder arthroplasty for proximal humeral fractures in elderly patient, musculoskeletal surgery xxxxxx , pages 1-6 (italy).This retrospective study aims to compare clinical and radiological outcomes in patients older than 65, who were treated with orif or rtsa for 3- or 4-part proximal humeral fractures.Between january 2009 and june 2017,63 patients between 65 and 85 years were treated with a surgical approach (orif or rtsa) for 3- or 4-part proximal humeral fracture (ao-ota type 11-b2 or 11-c2).Out of these patients , 48 patients were included in the study.The 48 patients were divided into two groups depending on the kind of treatment.The first group was composed of 26 patients age 73 ± 7.1 years who were treated with philos plate (synthes, paoli, pa, usa) and followed up at 40 ± 25.4 month.The second group was composed of 22 patients age 75.5 ± 5.6 years who were treated with reverse total shoulder arthroplasty (lima corporate, san daniele del friuli, italy) and followed up at 33.4 ± 10.4 months.The following complications were reported as follows: out of these 63 patients, 10 dropped out of the study due to death.The group treated with plate was characterized by 5 cases of avascular necrosis of the humeral head, in particular, 4 cases were complete necrosis and 1 case was partial necrosis.3 out of 5 patients with necrosis required a surgical revision with reverse arthroplasty because of the persistent pain and poor rom.3 cases of loss of reduction with varus displaced humeral head,in 2 cases of varus dislocation, a second reduction and fixation with plate was needed, (1 of those had a screw cutout) and 1 case of deep infection, a two-step surgery was necessary.Also, we registered 2 cases of great tuberosity malunion.3 cases of loss of reduction with varus displaced humeral head (1 of those had a screw cutout) in the patient with screw cutout, the removal of internal devices after fracture healing was sufficient.2 cases of subacromial plate impingement,the plates were removed after fracture healing.This report is for an unknown synthes philos plate.This report is for one (1) unk - plates.This is report 4 of 4 for (b)(4).

• Brand Name: UNK - PLATES
• 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: 10779527
• MDR Text Key: 214599152
• Report Number: 8030965-2020-08526
• 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: 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
• Device Catalogue Number: UNK - PLATES: TRAUMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/03/2020
• 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