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

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

Patient Problem Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - constructs: plate/screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.Implantation date is unknown.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.Without a lot number the device history records review could not be completed.Product was not returned.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

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: tang, x.Et al (2014), comparison of early and delayed open reduction and internal fixation for treating closed tibial pilon fractures, foot & ankle international, vol.35 (7), pages 657-664, doi: 10.1177/1071100714534214 (china).The aim of this retrospective study is to compare the results of early orif with delayed orif in treating closed, tibial type c pilon fractures.Between january 1, 2007 to december 31, 2012, a total of 46 patients (34 male and 12 female) underwent open reduction and internal fixation (orif).These patients were grouped according to group a (n=23; early group) with a mean age of 45.11 ± 11.67, and group b (n=23; delayed group) with a mean age of 44.26 ± 11.28.Surgery was performed using a large ao reduction clamps and distal metaphyseal locking plate (ao, synthes, switzerland).The mean follow-up time was 25.8 months (range, 14 to 48 months) in group a and 26.0 months (range, 15 to 44 months) in group b.The following complications were reported as follows: group a: 3 patients had a superficial infection which was cured within 2 weeks with a change of dressing followed by 3 to 7 days of antibiotic treatment.2 patients had fair results in their fracture reduction.2 patients had delayed union.9 patients had radiological evidence or arthritis symptoms.A (b)(6)-year-old female patient had a narrowed joint gap at forty-two months after surgery.Group b: 1 patient had a superficial infection which developed into a deep wound infection which was cured by additional debridement surgery followed by 14 days of antibiotic treatment.5 patients had fair results in their fracture reduction.4 patients had delayed union.14 patients had radiological evidence or arthritis symptoms.This report is for an unknown synthes plate and screws construct.A copy of the literature article is being submitted with this medwatch.This is report for 02 of 02 of (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE,FIXATION,BONE
• 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: 9204020
• MDR Text Key: 170445422
• Report Number: 8030965-2019-69415
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• 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: 10/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR