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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown plates: dhs/dcs/unknown lot.Part and lot numbers are unknown; udi number is unknown.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn.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.(b)(4).
 
Event Description
Device report from synthes reports an event in austria as follows: this report is being filed after the review of the following journal article: kukla, c.Et al (2000),indications for implant removal in healed proximal femoral fractures , acta chirurgica austriaca(2000)volume 32 number 4, pages 196-198 (austria).This retrospective study aims to work out the indications for hardware removal and to work out possibilities of preventing superfluos surgery.Between 1992 to 1998 ,a total of 2553 patients who received either a dynamic hip screw® (dhs) (rob.Mathys, switzerland)or a gamma locking nail ® (gn) (howmedica international,germany) were retrospectively analysed.Of these patients, 81 (32 males 49 females)patients whose ages at the time of the reoperation ranged from 22 to 93 years (mean: 68.3 years: sd:20.4)and who had implant removal due to complications were included in the study.Forty-four (44) patients (17 male 27 female) with a mean age of 68.6 years (sd: 18.2; range: 22.4 - 92.5) were treated with dynamic hip screw® (dhs) (rob.Mathys, switzerland) and thirty seven (37) patients (15 males 22 female)with a mean age of 68.0 years (sd: 20.4: range: 24.9 - 92.0) were treated with a gamma locking nail ® (gn) (howmedica international,germany).The following complications were reported as follows: 7 patients had implant removal due to deep infection followed bv thr in two and leaving a septic girdlestone situation in five cases.18 patients had implant removal due to avascular necrosis of the femoral head and total hip replacement in all of the cases.3 patients had implant removal due to ipsilateral shaft fracture.1 patient had implant removal due to pseudarthrosis.10 patients had implant removal due to request without any forcing complication.1 patient had implant removal due to cutting-out of the lag-screw 1 patient had implant removal due to pain caused by a neck screw.1 patient had implant removal due to malposition of the lag screw anteriorly.1 patient had implant removal due to implant loosening of plate and screws laterally.This report is for an unknown 2 hole plate and 4-hole plate synthes dynamic hip screw (dhs).These impacted products capture this complication: 1 patient had implant removal due to implant loosening of plate.This report is for one (1) unk - plates: dhs/dcs.This is report 6 of 7 for (b)(4).
 
Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 corrected data b6 e1 g1 g3 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.
 
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Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8680915
MDR Text Key147448455
Report Number8030965-2019-65097
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received06/12/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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