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 Arthritis (1723); Discomfort (2330); Non-union Bone Fracture (2369)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates: 3.5 mm lcp clavicle hook 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.(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, as no product was received.Investigation summary - 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, 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: erdle, b.Et al (2017), comparative analysis of locking plate versus hook plate osteosynthesis of neer type iib lateral clavicle fractures, archives of orthopaedic and trauma surgery, vol.137(5), pages 651-662 (germany).This retrospective, comparative cohort study aims to analyze and compare radiological results, functional outcomes and complications of locking plate osteosynthesis (lpo) versus hook plate osteosynthesis (hpo).For the last 12 years, a total of 32 patients (28 male and 4 female) underwent operative treatment for acute lateral clavicle fractures.Of these patients, 19 patients with a mean age 44.3±14.9 years were treated with 3.5 mm lcp clavicular hook plate (depuy synthes, west chester, usa) while 13 patients with a mean age of 43.7±13.7 were treated with 3.5 mm locking compression t-plate (depuy synthes) respectively for (7) patients and 2.7/3.5 mm locking compression superior lateral clavicle plate respectively for (6) patients.Standardized radiographs were routinely performed postoperatively, after 3, 4.5, 6, 12 months and then annually as needed.Mean follow-up period was 54.2 months (range, 25.2 ¿ 111.4 months.The following complications were reported as follow under hpo: a (b)(6) years-old at follow-up obtained a satisfactory outcome.This patient showed a symptomatic subacromial impingement syndrome with a mildly positive starter test.1 patient with a fair result suffered from symptomatic non-union of the lateral clavicle following hook plate osteosynthesis.2 patients had delayed union.1 patient had peri-implant fracture 6 weeks after surgery at routine follow-up examination without any history of trauma.5 patients had acromial osteolysis at follow-up.8 patients had posttraumatic acj arthrosis.Of these patients 1 showed mild clinical symptoms and did not require secondary surgery.The following complications were reported as follow under lpo: the article did not specify which of the 3.5 mm lcp t-plate or 2.7/3.5 mm lcp superior lateral clavicle plate had caused the complications.3 cases of lpo implants were removed after a mean time-period of 12.5 months on explicit patients request due to a subjective sense of local irritation.3 patients had delayed union.1 patient had posttraumatic acj arthrosis.This report is for an unknown synthes 3.5 mm lcp clavicular hook plate, unknown synthes 3.5 mm locking compression t-plate and unknown synthes 2.7/3.5 mm locking compression superior lateral clavicle plate.This is report 4 of 4 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: 8278495
• MDR Text Key: 134194168
• Report Number: 8030965-2019-60364
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• 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: 01/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention