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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONDYLAR PLATE FIXATION IMPLANT

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OBERDORF SYNTHES PRODUKTIONS GMBH CONDYLAR PLATE FIXATION IMPLANT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Calcium Deposits/Calcification (1758); Joint Dislocation (2374); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

510k: this report is for an unknown - plates: distal radius/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. The investigation could not be completed; no conclusion could be drawn. 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. (b)(4).

 
Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: bhatia dn and page rs (2012). "surgical treatment of lateral clavicle fractures associated with complete coracoclavicular ligament disruption: clinico-radiological outcomes of acromioclavicular joint sparing and spanning implants. " international journal of shoulder surgery, volume 6, issue 4, pages 116-120 (india). The purpose of this retrospective study was (1) to analyze the overall and comparative clinico-radiological outcomes (radiographic and ultrasonographic) of surgical treatment of distal clavicle fractures associated with complete coracoclavicular ligament disruption, and (2) to identify and analyze radiographic patterns of fracture and comminution that are associated with this injury. Between 2005 and 2008, a total of 15 patients with acute, isolated, non-comminuted and comminuted fractures of the lateral clavicle who underwent osteosynthesis were included in the study. There were 13 males and 2 females with an average age of 34. 5 years (range, 20 to 57 years). Patients were divided into 2 groups: 10 patients were operated using a joint-spanning implant (group 1) and 5 were operated using a joint-sparing implant technique (group 2). Patients in group 1 were implanted with an unknown synthes clavicle hook plate. Patients in group 2 were implanted with an unknown synthes 2. 4mm locking compression plate (lcp) distal radius plate along with some form of coracoclavicular fixation using a competitor¿s sutures/anchors/endobutton devices. Follow-up included clinical evaluation, radiographic evaluation and, ultrasonographic evaluation. Clinical outcomes were measured using constant score (cs), simple shoulder test (sst), and walch acj score (ws). Radiographs and ultrasonography were used to assess the glenohumeral and acromioclavicular joints and the subacromial space. Mean follow-up period is 26. 1 months (range, 12 to 40 months). Complications were reported as follows: group 1 (with clavicle hook plate): 5 patients had acromioclavicular joint signs. 1 patient had rotator cuff signs. 9 patients had a revision with implant removal. 1 patient had nonunion with subsequent fragment resorption. 3 patient had acromioclavicular joint degeneration. All 3 patients had a clinically symptomatic acromioclavicular joint 1 patient had an acromioclavicular subluxation (grade 2). 6 patients had an abnormal bone formation. 1 patient had supraspinatus lesions that included partial articular-side tears seen in ultrasonographic outcomes. 1 patient had supraspinatus lesion with supraspinatus bursal-side degenerative changes seen in ultrasonographic outcomes. 1 patient had an abnormal subacromial bursal "bunching" with arm abduction. 5 patients had subacromial osteolysis and hook migration. 4 of these patients required implant removal. Resolution of the radiographic subacromial osteolytic lesions was observed at final follow-up. 3 patients had signs of progressive implant loosening (plate disengagement). Group 2 (with lcp distal radius plate): 2 patients had acromioclavicular subluxation (grade 1). 1 patient had acromioclavicular subluxation (grade 2. ) 1 patient had an abnormal bone formation. 1 patient had supraspinatus lesions that included partial articular-side tear. 1 patient had an abnormal subacromial bursal "bunching" with arm abduction seen in ultrasonographic outcomes. This impacted product captures the reported unknown 2. 4mm locking compression plate (lcp) distal radius plate with the following adverse events: acromioclavicular subluxation; abnormal bone formation; supraspinatus lesions (partial articular-side tear); abnormal subacromial bursal "bunching". This report is for two (3) devices- an unknown ao clavicular hook plate, unknown synthes 2. 4mm locking compression plate (lcp) distal radius plate and unknown synthes screws. This is report 5 of 5 for (b)(4).

 
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Type of DeviceCONDYLAR PLATE FIXATION IMPLANT
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key8275459
MDR Text Key134065343
Report Number8030965-2019-60275
Device Sequence Number1
Product Code JDP
Combination Product (Y/N)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/24/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2019
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: 01/24/2019 Patient Sequence Number: 1
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