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 Problem Injury (2348)

Event Date 07/11/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown locking compression plate (lcp) construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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: yuan, y.Et al.(2020), clinical outcomes of revision with retrograde intermedullary nailing for failed plating of distal femoral fractures: a retrospective study, international orthopaedics, vol.Xx, pages 1-6 (china).The purpose of this study is to assess the feasibility and effectiveness of retrograde intramedullary nail (rin revision surgeries for locking compression plate (lcp) failure in distal femoral fractures.Between january 2014 and december 2016, patients with distal femoral fractures underwent open reduction and locking compression plate (lcp) fixation.13 patients (11 males and 2 females; ranged in age from 22 to 63 years old, with a mean age of 45.6 ± 4.0 years) suffering from metalwork failures after initially undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures eventually underwent rin.The average duration from lcp fixation to metalwork failure was one¿18 months (mean, 8.0 ± 5.5 months).The following complications were reported as follows: patient 1: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.Patient 2: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.Patient 3: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.Patient 4: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.Patient 5: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.Patient 6: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.Patient 7: a (b)(6) year old female patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.Patient 8: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.Patient 9: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.Patient 10: a (b)(6) year old female patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.Patient 11: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.Patient 12: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.Patient 13: a (b)(6) year old male patient had a metalwork failure after undergoing open reduction and locking compression plate (lcp) fixation for distal femoral fractures.This report is for an unknown synthes locking compression plate (lcp) construct.It captures the reported (b)(6) year old female patient who had a metalwork failure.This is report 7 of 10 for (b)(4).Additional devices are reported under related complaint (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: 10538327
• MDR Text Key: 207328023
• Report Number: 8030965-2020-07007
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• 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: 08/20/2020
• 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: 57 YR