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

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

Patient Problems Ossification (1428); Pulmonary Embolism (1498); Arthritis (1723); Necrosis (1971); Nerve Damage (1979); Post Operative Wound Infection (2446); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - constructs: plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history record has been requested.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 china reports an event as follows: this report is being filed after the review of the following journal article: wang, p.Et al.(2020), the effect of new preoperative preparation method compared to conventional method in complex acetabular fractures: minimum 2-year follow-up, archives of orthopedic and trauma surgery, vol.Xx, pages 1-8 (china).This study aimed to compare the efficacy and safety of the new method including 3d printing-based preoperative planning, surgical workshop, and contouring of the plate versus conventional method in the surgical treatment of complex acetabular fractures.From february 2013 to february 2016, 88 patients with acetabular fractures treated by open reduction internal fixation.There were 61 males and 27 females with a mean age of 43.98 ± 12.09 (range 21¿72 years).The patients were divided into 2 groups; group 1 consisted of 41 patients who were treated with the new method while group 2 consisted of 47 patients who were treated with the conventional method.Implants used were pelvic reconstruction plates (synthes, switzerland).Mean follow- up was 29.95 ± 4.84 months (range 24¿41 months).The following complications were reported as follows: 13 patients developed venous thromboembolism including 11 patients who developed deep vein thrombosis and 2 patients who developed non-fatal pulmonary embolism in group 1.16 patients developed deep vein thrombosis in group 2.7 patients sustained lateral femoral cutaneous nerve (lfcn) injuries.1 patient had a deep infection which was treated with debridement and irrigation and antibiotics.According to brooker classification, 5 patients had the class i heterotopic ossification without clinical symptoms.According to kellgren¿lawrence classification system, 3 patients were diagnosed as grade 4 and 1 patient as grade 3 osteoarthritis.2 of the patients with grade 4 arthritis had also ficat¿arlet stage 4 avn and both underwent total hip arthroplasty.But the other patient refused the total hip arthroplasty in group 2.15 patients had poor outcomes in the radiographic grades (matta scores grading).9 patients had fair outcomes and 12 patients had poor outcomes with the modified postel merle d¿aubigne.This report is for an unknown synthes reconstruction plate.

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11101959
• MDR Text Key: 227506834
• Report Number: 8030965-2020-10074
• 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: Physician
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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: 12/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention