MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE,FIXATION,BONE

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

Patient Problem Calcium Deposits/Calcification (1758)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown plate.Pma/510(k) number is not available.Product was not returned.Based on the information available, it has been determined that no corrective and 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.[(b)(4)].

Event Description

This report is being filed after the review of the following journal article: zhao, j.Et al (2018), intercalary prosthetic reconstruction for pathologic diaphyseal humeral fractures due to metastatic tumors: outcomes and improvements, journal of shoulder and elbow surgery, vol.27(11), pages 2013-2020 ((b)(6)).The purpose of this retrospective case-control study is to evaluate the outcomes and complications of intercalary humeral prosthetic reconstruction for pathologic diaphyseal fractures caused by metastatic lesions.Between 2011 and september 2017, a total of 9 patients (4 male and 5 female) with a mean age of 62.9±11.1 years (range, 50-82 years) underwent intercalary prosthetic reconstruction for pathologic diaphyseal humeral fractures secondary to metastatic diseases.Procedures were intercalary prosthetic reconstruction in 4 patients (group a) and an implanted intercalary prosthesis with a plate in 5 patients (group b).For the proximal, midshaft, or distal diaphyseal site of pathologic humeral fractures, we added a philos plate (depuy (b)(4) usa), a straight plate, or a condylar plate, respectively all patients had postoperative radiograph evaluation by the same surgeon until the latest examination included in this study or earlier death.Outpatient follow-up was performed monthly for 3 months, followed by interval of 2 or 3 months for the remaining follow-up.Follow-up was 11.5±10.1 months for group a and 6.2±4.4 months for group b.The following complications were reported as follow under group a: (non-synthes).4 (all) patients had died.A (b)(6) female had aseptic loosening but was able to achieved acceptable functional outcome due to preservation of adjacent joints.A (b)(6) male had radial nerve injury but was able to return to normal within 3 months after surgery.An (b)(6) did not survive for 3 months due to sudden complications from heart disease.The following complications were reported as follow under group b: (with plates).3 patients had died.A (b)(6) male with an additional plate for pathologic fracture of midshaft of left humerus had formation of a bone bridge linking the stem and the proximal fragment encasing the distal implant with heterotopic bone.This report is for an unknown synthes proximal humeral internal locking system (philos) plate.This is report 1 of 1 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8207204
• MDR Text Key: 131788774
• Report Number: 8030965-2018-59350
• 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: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/31/2018
• 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: 50 YR