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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 09/01/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 on (b)(6) 2021, during a procedure the screw did not fit into the plate. There were no fragments generated. There was a surgical delay of five (5) minutes. The procedure was completed successfully. There was no patient consequence. This report involves one (1) 135 deg lcp dhs plate-standard barrel 4 holes/92mm-sterile. This is report 1 of 2 for (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 BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12567948
MDR Text Key274448812
Report Number8030965-2021-08309
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number02.224.224S
Device Lot Number91P6078
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/04/2021 Patient Sequence Number: 1
Treatment
DHS/DCS-SCR Ø12.5 L90 SST
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