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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 135 DEG LCP DHS PLATE-STANDARD BARREL 4 HOLES/92MM-STERILE PLATE, FIXATION, BONE

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SYNTHES GMBH 135 DEG LCP DHS PLATE-STANDARD BARREL 4 HOLES/92MM-STERILE PLATE, FIXATION, BONE Back to Search Results
Catalog Number 02.224.224S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  Malfunction  
Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Device is not distributed in the united states, but is similar to device marketed in the usa. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on an unknown date in 2021 the locking compression (lcp) dynamic hip system (dhs) plate did not fit to the lcp dhs screw as it should. The procedure was completed successfully with no delay. No further information provided. This report is for one (1) 135 deg lcp dhs plate-standard barrel 4 holes/92mm-sterile this is report 1 of 1 for complaint (b)(4).

 
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Brand Name135 DEG LCP DHS PLATE-STANDARD BARREL 4 HOLES/92MM-STERILE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK GRENCHEN (CH)
solothurnstrasse 186
grenchen 2540
SZ 2540
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12371180
MDR Text Key268263411
Report Number8030965-2021-07227
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/16/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number02.224.224S
Device LOT Number138P134
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/01/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/29/2021
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/26/2021 Patient Sequence Number: 1
Treatment
LCP DHS SCREW
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