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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Calcium Deposits/Calcification (1758); Pain (1994); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown plate/unknown lot. Part and lot number 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. (b)(4).
Event Description
This report is being filed after the review of the following journal article: ruden c et al (2016). The missing effect of human recombinant bone morphogenetic proteins bmp-2 and bmp-7 in surgical treatment of aseptic forearm nonunion. Injury, international journal of the care of the injured. Volume 47. Page 919-924. (germany). The aim of the study was to evaluate this concept in a large number of patients and to determine if osseous healing of aseptic ulna and/or radius shaft nonunion in a high percentage was depending on the additional application of bmps. Between january 2005 and march 2015, 49 patients who were treated for a forearm (ulnar and/or radial shaft) fracture and had developed aseptic diaphyseal ulnar and/or radial shaft nonunion were included in the study. There were 38 men and 11 women with a median age of 44 years (range 19 to 77). All patients were revised with an unknown synthes locking compression plate. 24 patients obtained compression plating either with autologous iliac crest bone grafting (11/24 patients) or cancellous bone grafting (13/24 patients) and additional application of a competitor's bmp- 2 (4/24 patients) or bmp-7 (20/24 patients). The remaining 25 patients did not receive any additional application of bmp, but autologous bone grafting. The clinical outcome was assessed using the system by anderson et al. This functional scoring system for the upper limb rates a complete bone healing with less than 10 degrees loss of elbow or wrist motion and less than 25 percent loss of forearm rotation as excellent, a healed fracture with less than 20 degrees loss of elbow or wrist motion and less than 50 percent loss of forearm rotation as satisfactory, a healed fracture with more than 30 degrees loss of elbow or wrist motion and more than 50 percent loss of forearm rotation as unsatisfactory, and a malunion or nonunion as failure. Clinical and radiological follow-up studies were performed at regular intervals, 2 weeks, 6 weeks, 3 months, and 6 months following nonunion revision. The median follow-up was 15 months (range 6¿54 months). Complications were reported as follows: 4 patients had breakage of the revision implant. 1 patient had developed a chronic regional pain syndrome (crps) after revision. 1 patient had ectopic ossification that occurred during the healing process after revision. Fig. 3 (b) 1 patient had no radiological signs of osseous healing at 6 weeks after revision. Fig. 4 (b) 1 patient had no progress of bone graft integration or increasing bone formation at the nonunion site at 3 months post revision. Fig. 5 (b) 1 patient had no osseous healing of the ulnar shaft nonunion at 6 months after revision surgery and complete healing of the radial shaft. 2 patients developed posttraumatic joint arthritis in the elbow. 2 patients developed posttraumatic joint arthritis in the wrist. 1 patient developed posttraumatic joint arthritis for both elbow and the wrist. 5 patients had an unsatisfactory anderson functional score. 4 patients had failure anderson functional score. This report is for an unknown synthes locking compression plate. This is report 3 of 4 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
MDR Report Key8621777
MDR Text Key145474204
Report Number8030965-2019-64138
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/17/2019 Patient Sequence Number: 1