MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: DHS/DCS; APPLIANCE, FIXATION, NAIL

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

Patient Problems Inflammation (1932); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Multiple patient was involved in the study.510k: this report is for an unk - constructs: dhs/dcs/unknown lot.Part and lot numbers are unknown; udi number is unknown.Implant date: unknown date.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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

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: lee, j.Y.Y.Et al (2015), bisphosphonate-associated peri-implant fractures: a new clinical entity? a series of 10 patients with 11 fractures, acta orthopaedica, vol.86 (5), pages 622-626 (usa).The aim of this retrospective study is to assess similarities with classical atypical femoral fractures (affs) and how their location may have implications for the pathogenesis and management of affs.Between 2006 to 2013, a total of 10 female patients, with a mean age of 80 (70¿92) years, sustained 11 peri-implant fractures and were included in the study.3 of these patients had an initial surgery using dynamic hip screw.The mean follow-up period was unknown.The following complications were reported as follows: an (b)(6) year-old female patient had a peri-implant femoral fracture.She underwent dhs removal and revision surgery.Histology samples from the fracture site were obtained and showed reactive inflammatory tissue and were not malignant.A (b)(6) year-old female patient had a peri-implant femoral fracture.She underwent dhs removal and revision surgery.An (b)(6) year-old female patient had a peri-implant femoral fracture.She underwent removal of the implant, long dhs insertion, and iliac crest bone grafting.This report is for an unknown synthes dynamic hip screw constructs.

• Brand Name: UNK - CONSTRUCTS: DHS/DCS
• Type of Device: APPLIANCE, FIXATION, NAIL
• 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: 10310765
• MDR Text Key: 199988912
• Report Number: 8030965-2020-05158
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention