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 Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown anatomical locking compression plate (plate/screw construct)/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.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: zhao r., et al (2019) diagnosis and treatment of hyperextension bicondylar tibial plateau fractures, journal of orthopaedic surgery and research, volume 14 (1), pages 1-8 (china) https://doi.Org/10.1186/s13018-019-1220-z.This study aims to report the diagnosis, injury mechanisms, and imaging characteristics of hyperextension bicondylar tibial plateau fractures and to examine the indications and feasibility of the modified anterior midline incision as a treatment strategy.From april 2016 to february 2018, a total of 12 cases (8 males, 3 females) with an age range of 19¿61 years (average age, 42.4 years) of hyperextension bicondylar tibial plateau, fractures were treated.All patients underwent open reduction and internal fixation using an anatomical locking compression plates (depuy synthes, usa).A t-shaped locking plate was placed on the medial side of the tibial platform, and an l-shaped locking plate was placed on the lateral side.All patients were followed for at least three months.The average follow-up was 11.5 months (3¿24 months).The following complications were reported as follows: one patient had a subcutaneous hematoma at four days after the operation.The wound healed without skin edge necrosis and infection after dressing and drainage for several days.A case of a 48 year old male (patient no.1) treated with lcp had medial meniscus rupture and late wound infection.(same patient : one dual-incision patient developed a delayed type of infection at nine months of recovery.Antibiotic treatment failed to control the infection, which was finally cured by plate removal.) a case of a 36 year old male (patient no.2) treated with lcp had lcl injury.A case of a 34 year old female (patient no.3) treated with lcp had mmr, lcl injury and popliteal artery embolism.A case of a 19 year old male (patient no.4) treated with lcp had popliteal artery embolism.A case of a 61 year old male (patient no.6) treated with lcp had deep vein thrombosis.(one of the two patients who developed deep vein thrombosis (dvt) and received placement of a temporary filter.) a case of a 39 year old male (patient no.7) treated with lcp had lateral meniscus rupture, popliteal artery embolism, common peroneal nerve injury.A case of a 61 year old female(patient no.8) treated with lcp had deep vein thrombosis.(one of the two patients who developed deep vein thrombosis (dvt) and received placement of a temporary filter.) a case of a 26 year old patient female (patient no.9) treated with lcp had lateral meniscus rupture.This is report 6 of 8 for (b)(4).This complaint is linked to (b)(4).This report is for an unknown synthes anatomical locking compression plate (plate/screw construct) patient 8-61 year old female.A copy of the literature article is being submitted with this medwatch.

• 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: 10528472
• MDR Text Key: 215261481
• Report Number: 8030965-2020-06921
• 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: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• 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: 08/18/2020
• 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: 61 YR