MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 12/20/2014

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.(b)(4).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:wurm m., et al (2014) the midfoot fusion bolt: a new perspective? ,orthopäde, volume 44, pages 65¿70 (austria).This study aims to investigate short-term results in the use of midfoot fusion bolt including complications and review published surveys.Between 2009 and 2014, a total of 16 patients (8 male and 9 female), average age at surgery was 55.47 (42-70) years, who underwent surgical therapy for midfoot charcot were included in the study."midfoot fusion bolt" by depuy synthes was used.In all patients, various ao screws and plate sets were also used.Postoperative controls were scheduled after 4 weeks and after 8 and 12 weeks to monitor satisfactory consolidation.An average follow-up interval was 26.58 (3-55) months.The following complications were reported as follows: two patients died during the aftercare period, but in both cases there was no relation to charcot foot disease.Due to infections, a total of 2 amputations were necessary, with one amputation according to syme being performed.The reasons for the amputations were a chronic osteomyelitis and an infection with ulceration after a minor injury.3 cases a revision operation had to be performed due to the need to change the osteosynthesis material.Consecutive operations were necessary, 6 of which were screw removal and 2 amputations.Consecutive operations were necessary,4 wound revisions and 3 new arthrodeses.2 talus necroses.4 cases where "fusion bolt" were removed postoperatively due to signs of loosening.2 cases where the "fusion bolt were removed postoperatively were at the request of the patients.This report is for an unknown synthes screws.This is report 4 of 4 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,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: 9078184
• MDR Text Key: 162981943
• Report Number: 8030965-2019-68377
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2019
• 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