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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LCP SCREW, FIXATION, BONE

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SYNTHES GMBH UNK - CONSTRUCTS: LCP SCREW, FIXATION, BONE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative

Pma/510k: this report is for an unk: constructs: lcp/unknown lot. Part and lot numbers are unknown; udi 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.

 
Event Description

This report is being filed after the review of the following journal article: chung, s. -t. Et al (2009), treatment of distal tibia fracture using mippo technique with locking compression plate: comparative study of the intraarticular fracture and extraarticular fracture, journal of korean foot and ankle society, vol. 13 (2), pages 162-168 (korea, south). The aim of this study is to evaluate the efficiency of the minimally invasive percutaneous plate osteosynthesis (mippo) with locking compression (lcp) for distal tibial metaphyseal intra-articular fracture compared with extra-articular fracture. Between february 2006 to june 2008, a total of 41 patients who were treated operatively by mippo technique were included in the study. They were divided into extra-articular fractures and intra-articular fractures. In the extra-articular fractures, there were 20 patients (10 male and 10 female) with a mean age of 52. 35 years (range: 28-77 years). In the intra-articular fractures, there were 21 patients (15 male and 6 female) with a mean age of 48. 85 years (range: 24-76 years). Surgery was performed using a locking compression plate (lcp, distal medial tibia plate, synthes, swiss). The mean follow-up period for the intra-articular fracture and extra-articular fracture was 14. 5 months (range: 12-19 months) and 15 months (range: 12-23 months), respectively. The following complications were reported as follows: a (b)(6) female patient had skin irritation/discomfort due to the protrusion of the distal part of the plate; had 5 degrees dorsiflexion limitation compared to the unaffected side. A (b)(6) female patient had skin irritation/discomfort due to the protrusion of the distal part of the plate; had 5 degrees dorsiflexion limitation compared to the unaffected side. A (b)(6) female patient had 10 degrees dorsiflexion limitation compared to the unaffected side. A (b)(6) male patient had 5 degrees plantar flexion limitation compared to the unaffected side. A (b)(6) female patient with diabetes mellitus developed skin necrosis at the surgical site but was healed with conservative treatment; had 5 degrees dorsiflexion limitation compared to the unaffected side. A (b)(6) male patient developed a superficial infection, but it improved with antibiotic treatment. A (b)(6) female patient had 15 degrees plantar flexion limitation compared to the unaffected side. A (b)(6) male patient had 5 degrees dorsiflexion limitation compared to the unaffected side. A (b)(6) male patient had skin irritation/discomfort due to the protrusion of the distal part of the plate; had 5 degrees dorsiflexion limitation and 15 degrees plantar flexion limitation compared to the unaffected side. A (b)(6) female patient developed skin necrosis; had 5 degrees and 15 degrees of dorsiflexion and plantar flexion limitation, respectively. A (b)(6) male patient had 5 degrees dorsiflexion limitation. A (b)(6) male patient had 5 degrees dorsiflexion limitation. A (b)(6) female patient had 5 degrees dorsiflexion limitation. A (b)(6) male patient had skin irritation/discomfort due to the protrusion of the distal part of the plate. A (b)(6) male patient had 5 degrees plantar flexion limitation. A (b)(6) female patient had both 5 degrees dorsiflexion and plantar flexion limitation. A (b)(6) male patient had skin irritation/discomfort due to the protrusion of the distal part of the plate; had 5 degrees of plantar flexion limitation. A (b)(6) female patient had 5 degrees plantar flexion limitation. A (b)(6) male patient had both 5 degrees of dorsiflexion and plantar flexion limitation. A (b)(6) female patient had both 10 degrees of dorsiflexion and plantar flexion limitation. A (b)(6) female patient had skin irritation/discomfort due to the protrusion of the distal part of the plate; had 5 degrees of plantar flexion limitation. A (b)(6) female patient had 15 degrees of plantar flexion limitation. A (b)(6) male patient had 5 degrees and 10 degrees of dorsiflexion and plantar flexion limitation, respectively. A (b)(6) male patient had 10 degrees and 5 degrees of dorsiflexion and plantar flexion limitation, respectively. A (b)(6) female patient had 5 degrees of dorsiflexion limitation. A (b)(6) male patient with an unsatisfactory result where the timing of the ankle movement was delayed due to post-operative skin necrosis in the open area and the plantar flexion limit was measured to be 20 degrees. Also, the time of bone union was late at 24 weeks. A (b)(6) male patient had both 5 degrees of dorsiflexion and plantar flexion limitation. A (b)(6) male patient had both 5 degrees of dorsiflexion and plantar flexion limitation. A (b)(6) male patient had both 10 degrees of dorsiflexion and plantar flexion limitation. A (b)(6) male patient had 5 degrees of plantar flexion limitation. A (b)(6) male patient had both 5 degrees of dorsiflexion and plantar flexion limitation. A (b)(6) female patient had 5 degrees and 10 degrees of dorsiflexion and plantar flexion limitation, respectively. A (b)(6) male patient had both 5 degrees of dorsiflexion and plantar flexion limitation. A (b)(6) male patient had 5 degrees of dorsiflexion limitation. A 61-year-old male patient had skin irritation/discomfort due to the protrusion of the distal part of the plate. A (b)(6) male patient had skin irritation/discomfort due to the protrusion of the distal part of the plate. This report is for an unknown synthes lcp medial distal tibial plate/screws constructs, unknown synthes lcp medial distal tibial plate, and unknown synthes locking screws. This report is for one (1) unk - constructs: lcp. This is report 1 of 2 for complaint (b)(4).

 
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Brand NameUNK - CONSTRUCTS: LCP
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12380535
MDR Text Key268689487
Report Number8030965-2021-07329
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 07/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/27/2021 Patient Sequence Number: 1
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