MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES; PLATE, FIXATION, BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cervical plates/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: leung k.S.,yuen k.M,chan w.S.,(1993),operative treatment of displaced intra-articular fractures of the calcaneum, the journal of bone and joint surgery, volume 75-b.Number 2 , pages 196-201 (hong kong).This study aims to assessed the three-year results of patients treated for displaced intra-articular fractures of the calcaneum by open reduction through a lateral approach, stable internal fixation and bone grafting, in comparison with those of conservative treatment.Since 1986, a total of 93 patients had been treated for displaced intra-articular fractures.Out of these, 44 patients (41 male and 3 female) with an average age of 36.3 (ranged 20 to 58) had operative treatment,and 19 patients (14 male and 5 female) with an average age of 43.8 (ranged 22 to 61) who had conservative management were included in the study.Operative treatment was by open reduction using one or two 4 mm ao cancellous screws through the subchondral bone.The space inside the calcaneum was then packed with autogenous corticocancellous chip grafts and the lateral wall reduced and buttressed with an ao cervical plate or an ao multifragment plate.Operative group was followed up for 34.8 months (ranged 25 to 51 months).The following complications were reported as follows: 2 patients had mild irritation of the peroneal tendons due to the screw heads after prolonged walking but there was no frank subluxation or dislocation.These symptoms were easily controlled by the topical application of anti-inflammatory agents.44 patients had a degree of pain 29.5±1.5 according to the result of the clinical assessment.44 patients had a degree of swelling 4.8±0.6 4 according to the result of the clinical assessment.4 patients had fair clinical grade.Lateral, axial and internal oblique views of the calcaneum three years after operative treatment showing minimal arthritic changes in the subtalar joint.This report is for an unknown synthes cervical plate.This is report 3 of 6 for complaint (b)(4).It captures reported events of pain and swelling.

• Brand Name: UNK - PLATES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8901501
• MDR Text Key: 154561463
• Report Number: 8030965-2019-67354
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• 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: 07/19/2019
• 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