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

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

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown dynamic compression plate and screw constructs/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: suk k., et al (2002) limb salvage using original low heat- treated tumor-bearing bone, clinical orthopaedics and related research number 397, pp.385¿393 (korea, south).This study aims to evaluate the outcome and usefulness of using original low heat treated tumor-bearing bone and a conventional joint prosthesis for limb salvage.From 1994 to 1998, a total of 12 patients had wide excision and limb salvage with original low heattreated tumor-bearing bone and a conventional prosthesis.Seven of the 12 patients were male and five were female, and the mean age at surgery was 26.1 years (range, 10¿58 years).Fixation was done using bone cement (depuy cmw 1 original bone cement, warsaw, in) and the stem of a conventional joint replacement prosthesis (depuy global shoulder system or depuy elite plus hip system).This construct then was fixed to the host bone (the normal distal portion of the femur or humerus) with a dynamic compression plate and cortical screws.The mean followup was 31.8 months (range, 11¿62 months).The following complications were reported as follows: a case of a (b)(6) year old female had non-union.The complication rate for patients requiring revision surgery was 25.0% (three of 12 patients).There were two cases where the original low heat-treated tumor-bearing bone was fractured and there was one case of marked absorption with nonunion, which required revision surgery.There was one patient with a hip dislocation 3 months after a total hip arthroplasty, and closed reduction was done successfully.There were two fractures of the low heat-treated tumor-bearing bone 7 months and 11 months after surgery, respectively.Both were caused by slipping accidents.One patient had osteosarcoma of the proximal humerus and the other had osteosarcoma of the proximal femur.Internal fixation was done with plate and screws.Absorption of the low heat-treated tumor-bearing bone occurred in four of the six patients with proximal humeral lesions (fig 1).Among those patients, one had severe absorption of the bone and nonunion, therefore, revision surgery was done.This report is for an unknown synthes dynamic compression plate and screw constructs.It captures reported following events: patients requiring revision surgery, two cases of original low heat-treated tumor-bearing bone fracture, one case of marked absorption with nonunion, which required revision surgery, one case of a hip dislocation 3 months after a total hip arthroplasty, two fractures of the low heat-treated tumor-bearing bone due to slipping accidents.One patient had osteosarcoma of the proximal humerus and the other had osteosarcoma of the proximal femur.Absorption of the low heat-treated tumor-bearing bone in four of the six patients with proximal humeral lesions (fig 1).Among those patients, one had severe absorption of the bone and nonunion, therefore, revision surgery was done.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10977062
• MDR Text Key: 220684746
• Report Number: 8030965-2020-09548
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• 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: 11/12/2020
• 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