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

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).

• Type of Device: CONDYLAR 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 Key: 8275459
• MDR Text Key: 134065343
• Report Number: 8030965-2019-60275
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• 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
• Date Manufacturer Received: 01/04/2019
• 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