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

Device Problem Break (1069)

Patient Problems Necrosis (1971); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Multiple patient involved.Implantation date is unknown.This report is for an unk - plate: 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.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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.

Event Description

Device report from austria reports an event as follows: this report is being filed after the review of the following journal article: lorenz, g.Et al (2020), complication rate after operative treatment of three- and four-part fractures of the proximal humerus: locking plate osteosynthesis versus proximal humeral nail, european journal of trauma and emergency surgery, vol.Xx (xx), pages 1¿10 (austria).The aim of this monocentric, retrospective study is to compare the complication rate after operative treatment of three- and four-part fractures of the proximal humerus with either a locking plate osteosynthesis or proximal humeral nail after a minimum follow-up of one year.Between january 2005 to december 2016, a total of 50 patients (13 male and 37 female) with a mean age of 59 years (range 26¿78 years) were included in this study.19 of these (11 three-part fractures and 8 four-part fractures) were treated with a proximal humeral nail expert® (depuy synthes, oberdorf, switzerland) (hn group) and 31 (12 three-part fractures and 19 four-part fractures) were treated with a philos® locking plate (depuy synthes, oberdorf, switzerland) (lp group).Follow-up monitoring included an accurate radiographic examination before discharge from hospital, and again at 6 weeks, 12 weeks, as well as 6 and 12 months after surgery.The mean follow-up period was unknown.The following complications were reported as follows: in one case, revision surgery (rtsa) was performed after fracture healing in malposition.Hn group: 6 patients suffered at least one complication within one year after surgery.4 patients suffered from a humeral head perforation caused by the implant.Of these, 3 were primary implant cutouts due to fracture sintering, and 1 was secondary implant cutouts after humeral head necrosis or nonunion.An example of cutout is presented in figs.2.3 patients had nonunion.1 patient presented with a loss of fixation.1 patient suffered from a wound infection.In 2 patients, a revision surgery was required including either screw exchange, replating, nailing, or conversion into rtsa.Lp group: 14 patients suffered at least one complication within one year after surgery.7 patients suffered from a humeral head perforation caused by the implant.Of these, 3 were primary implant cutouts due to fracture sintering, and 4 were secondary implant cutouts after humeral head necrosis or nonunion.An example of cutout is presented in figs.1.5 patients had nonunion.One case of consecutive plate failure due to non-union is presented in fig.3.6 patients presented with a loss of fixation.5 patients suffered from a humeral head necrosis (fig.4).In 6 patients, a revision surgery was required including either screw exchange, replating, nailing, or conversion into rtsa.This report is for an unknown synthes expert humeral nail constructs, unknown synthes plate/screws constructs, unknown synthes plates, and unknown synthes screws.This report is for (1) unk - plates.This is report 1 of 6 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: 10763727
• MDR Text Key: 217128865
• Report Number: 8030965-2020-08425
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2020
• 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