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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC UNK - PLATES: VA-LCP PLATE, FIXATION, BONE

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WRIGHTS LANE : SYNTHES USA PRODUCTS LLC UNK - PLATES: VA-LCP PLATE, FIXATION, BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2021
Event Type  malfunction  
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 for a procedure. During the procedure the do not screw or stay on the plate to allow to drill for lock screws. It was unknown if the surgery completed successfully. The patient outcome was unknown. Concomitant devices reported: unknown lcp plate (part# unknown, lot# unknown, quantity 1), unknown locking screws (part# unknown, lot# unknown, quantity unknown). This complaint involves two (2) devices. This report is for (1) unk - plates: va-lcp this report is 1 of 2 for (b)(4).
 
Manufacturer Narrative
Product complaint #: (b)(4). Additional narrative: 510k: this report is for an unk - plates: va-lcp/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. 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. Based on the information available, it has been determined that no corrective and preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. 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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Brand NameUNK - PLATES: VA-LCP
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13079212
MDR Text Key287891908
Report Number8030965-2021-10424
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/23/2021 Patient Sequence Number: 1
Treatment
LCP DRILL SLEEVE 1.5 F/DRILL BIT Ø1.1; UNK - PLATES: TRAUMA; UNK - SCREWS: LOCKING
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