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

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

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate and screw construct/unknown lot.Part and lot number 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.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.

Event Description

This report is being filed after the review of the following journal article: jain, d.Et al (2020), functional outcome of open distal femoral fractures managed with lateral locking plates, international orthopaedics, vol.44 (xx), pages 725¿733 (india).The aim of this prospective observational study is to evaluate the functional outcome and union rates of open distal femoral fractures managed with anatomic lateral locking plates.Between june 2015 to december 2017, a total of 34 patients (28 male and 6 female) with an average age of 40.8 years (range 20¿65 years) were included in the study.Surgery was performed using either a titanium (synthes, distal femur lcp) or a stainless-steel from a competitor.Titanium plate was used in 79.4% (n = 27) cases, while in 20.6% (n = 7) cases, stainless steel plate was used.The average follow-up period was 11.6 months (range 8¿22.5 months).The following complications were reported: 2 patients died in the early post-operative period (one each due to head injury and adult respiratory distress syndrome).The number of secondary procedures for the whole group was 27 with an average of 0.79 additional procedures per patient.A (b)(6) year old female patient had distal screw failure with union of the fracture, thus no active intervention was done.A (b)(6) year old male patient had superficial wound infection which resolved with oral antibiotics.A (b)(6) year old female patient had nonunion and underwent bone grafting to achieve bone union.A (b)(6) year old male patient had nonunion associated with failure of one proximal screw and required addition of two proximal screws along with bone grafting.A (b)(6) year old male patient had nonunion and underwent bone grafting to achieve bone union.A (b)(6) year old male patient had nonunion and underwent bone grafting to achieve bone union.A (b)(6) year old female patient had nonunion and underwent bone grafting to achieve bone union.A (b)(6) year old male patient had nonunion and underwent bone grafting to achieve bone union.A (b)(6) year old female patient had nonunion and underwent bone grafting to achieve bone union.A (b)(6) year old male patient had nonunion and underwent bone grafting to achieve bone union.A (b)(6) year old male patient had deep infection three weeks after primary plating which was managed with wound debridement and extended course of intravenous antibiotics.This patient remained asymptomatic and went on to achieve fracture union.A (b)(6) year old male patient had quadriceps contracture.This report is for an unknown synthes plate/screws constructs and unknown synthes screws.This is report 4 of 4 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: 10758998
• MDR Text Key: 216880160
• Report Number: 8030965-2020-08387
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• 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: 10/02/2020
• 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
• Patient Age: 21 YR