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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Osteolysis (2377)
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. Pma/510(k) number is not available. Product was not returned. Device history records review could not be completed without lot number. 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: padolino a. Et al 2018). "comparison of cfr-peek and conventional titanium locking plates for proximal humeral fractures: a retrospective controlled study of patient outcomes. " musculoskeletal surgery. Volume 102. Page s49-s56 (italy). The purpose of this retrospective study was to compare the clinical and radiographic outcomes of three- and four-part proximal humeral fractures (phfs) treated with carbon fiber-reinforced polyetheretherketone (cfr-peek or metal (titanium) plates. Between january 2013 to december 2015, 42 patients who underwent internal fixation of 3 and 4 part proximal humeral fractures according to neer classification were identified and evaluated for the study. Accordingly, patients were divided into a cfr-peek group and a metal group. The cfr-peek group consisted of patient who were implanted with a competitor¿s device. The metal group consisted of 21 patients (7 males and 14 females, average age of 55. 8 years (range, 22-78 years)) who were implanted with an unknown synthes proximal humeral internal locking system (philos) plate and screws. Intraoperative fluoroscopy was used to check fragment reduction, plate position, and the length of the screws. At the end of the "rocedure", the arm was immobilized in a sling for 4 weeks. Active mobilization was allowed after 6 weeks and strength exercises after 8 weeks. Mean follow-up for the metal group was 57. 2 months (range, 29-77). Complications were reported as follows: 5 patients experienced moderate postoperative pain. 7 patients experienced postoperative mild pain. Unknown number of patients had cortical thinning at postoperative radiograph at the last follow-up. 9 patients had tuberosity resorption of greater than 50 percent at postoperative radiograph at the last follow-up. 2 patients had varus or valgus malalignment of the humeral head. 3 patients had screw perforation and cutout. A (b)(6) patient with poor bone quality had humeral head collapse and required revision with reverse prostheses. This report is for unknown proximal humeral internal locking system (philos) plate. This is report 1 of 5 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
MDR Report Key8222600
MDR Text Key132241156
Report Number8030965-2019-59501
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
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 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2019
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 Received12/12/2018
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: 01/07/2019 Patient Sequence Number: 1