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

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

Patient Problems Non-union Bone Fracture (2369); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes philos plate/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.(b)(4).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: shearman, a.Et al (2015).Use of a proximal humeral locking plate for complex ankle and hindfoot fusion, the journal of foot and ankle surgery, vol.55, pages 612-618 (united kingdom).The purpose of this study is to present the experience using proximal humeral locking plate (philos) for complex tibiotalar (tt), tibiotalocalcaneal (ttc), and tibiocalcaneal (tc) fusions.Between may 2003 to july 2011, a total of 21 patients (11 males and 10 females) with mean age of 56.1-years range 25 to 74 years were included in the study.Fracture fixation was fixed using philos (synthes, zuchwil, switzerland).The average follow-up period was 14.6 (median 10, range 6 to 49) months.The following complications were reported as follow: a (b)(6) year-old female with 15 coronal angular deformity and 10 sagital angular deformity who had a superficial infection which was treated with antibiotics.A (b)(6) year-old female with 30 coronal angular deformity and 15 sagital angular deformity who had a poor patient satisfaction which has mrsa non-union.A (b)(6) year-old female with 25 coronal angular deformity and 10 sagital angular deformity who had a poor patient satisfaction which has non-union and deep infection.A (b)(6) year-old male with 15 coronal angular deformity and 15 sagital angular deformity who had a poor patient satisfaction which has reactivation of charcot disease.A (b)(6) year-old female with 35 coronal angular deformity and 15 sagital angular deformity who had a loose screw requiring removal for local irritation.A (b)(6) year-old male with 20 coronal angular deformity and 5 sagital angular deformity who had a distal tibia fracture above plate.A (b)(6) year-old male with 20 coronal angular deformity and 20 sagital angular deformity who had peroneal tendonitis.A (b)(6) year-old female with 10 coronal angular deformity and 20 sagital angular deformity who had a wound breakdown 3 years after the surgery and the metalwork was removed.A (b)(6) year-old female with 30 coronal angular deformity and 5 sagital angular deformity who had a subtalar osteoarthritis.The complaint involves total 20 devices.Due to system limitation of impacted products per complaint, this complaint will be captured under 2 separate complaints as listed below: (b)(4).This report is for a (b)(6) year-old male with 15 coronal angular deformity and 15 sagital angular deformity who had a poor patient satisfaction which has reactivation of charcot disease.This report is for an unknown philos plate.This is report 6 of 7 for (b)(4).

• 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: 8355476
• MDR Text Key: 136732624
• Report Number: 8030965-2019-61165
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2019
• 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
• Patient Age: 49 YR