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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA PLATE,FIXATION,BONE

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WRIGHTS LANE : SYNTHES USA PRODUCTS LLC VA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA PLATE,FIXATION,BONE Back to Search Results
Catalog Number 04.111.531S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Additional product code: hwc. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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, the patient underwent surgery treating radius. In the surgery, the screw penetrated the screw hole. The distal part of the plate did not fit the bone, the surgeon ended up using another plate and finished the surgery. The surgery was completed within 30 minutes delay. The patient condition is stable. Concomitant device reported: unk insertion instruments: trauma (part# unknown; lot# unknown; quantity: 1). This complaint involves two(2) devices. This report is for (1) va-lcp-2-column drp2. 4 volar narr le sha. This report is 1 of 3 for (b)(4).
 
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Brand NameVA-LCP-2-COLUMN DRP2.4 VOLAR NARR LE SHA
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13012273
MDR Text Key285457914
Report Number8030965-2021-10246
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K092556
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.111.531S
Device Lot Number289P325
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/15/2021 Patient Sequence Number: 1
Treatment
UNK - PLATES: VA-LCP DISTAL RADIUS; UNK - SCREWS: VA LOCKING
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