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

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/ unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: ocalan e., ustun c., aktuglu k., (2019) locking plate fixation versus antegrade intramedullary nailing for the treatment of extra-articular distal femoral fractures, injury, int.J.Care injured volume 50 s3, pages 55¿62 (turkey), https://doi.Org/10.1016/j.Injury.2019.07.008.This retrospective study aims to examine and compare the functional outcomes of distal femur fractures treated with a fixed locked plate (lp) or an antegrade intramedullary nail (ain).Between january 2000 and march 2015, a total of 97 patients (49 male, 48 female) treated with lp or ain for extra-articular distal femoral fractures were included in the study.Of the included patients, 69 patients (30 males and 39 females) age 35.3 (18¿82), sd:17.8, underwent locked plate (lp) (4.5 mm curved lcp plate, synhes1, usa) and 28 patients (19 males and 9 females) age 48 (18-93), sd: 21.7 underwent antegrade intramedullary nail (ain)(smith & nephew richards, inc., memphis, tn, usa).The average follow up time was 45 (range: 10¿130) months in the lp group and 50 (range: 12¿130) months in the ain group.The following complications were reported as follows: deaths: among the 33 patients who were excluded 6 patients died.Fig.4 shows the fracture in a (b)(6) year old male, which was caused by a gunshot injury.The type of fracture was ao 33c1 and g.Anderson.There was no neurovascular injury.After debridement, the fracture was stabilized with lp.Five months after surgery, the plate broke, causing nonunion.The screws at the fracture site might have caused the nonunion.The plate was changed to ain, and 3 months later, union was achieved.One patient developed deep infection in lp group.He was (b)(6) years old and a smoker.Three months after the use of systemic antibiotics were union achieved.Following union, he was subjected to debridement and implant removal.Fig.5 shows a fracture in a (b)(6) year-old male.The patient had an extra-articular type ao 33 b 3 distal femur fracture on his left femur.Osteosynthesis of his femur was performed with an liss plate.One month after surgery, the patient still could not walk independently.Three months after surgery, the patient could walk without crutches, but still had pain at his knee.Six months after surgery, union was achieved, and the patient had no pain.The patient had 135 knee rom.Nonunion was seen in sixteen patients 11 were in the lp group.In the lp group, the plate was changed to an antegrade intramedullary nail in 3 nonunions, while 8 nonunions not only had their plate changed, but they also had it grafted with an autologous iliac crest bone graft.Superficial infection was seen in one patient.Eight patients in the lp group had malreduction.Four of these fractures were corrected with another surgery.Complications (19), re-operation (12), hardware failure (11).This report is for an unknown liss plate.This is report 5 of 5 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• 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: 10234271
• MDR Text Key: 201216799
• Report Number: 8030965-2020-04646
• Device Sequence Number: 1
• Product Code: HRS
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• 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
• Date Manufacturer Received: 06/30/2020
• 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