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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS INCORE LAPIDUS SYSTEM; SCREW
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NEXTREMITY SOLUTIONS INCORE LAPIDUS SYSTEM; SCREW Back to Search Results
Model Number IC-LAP-5928RP
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/09/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the incore post would not accept the screw in the lower hole.The post was removed, and a second post was used to complete the surgery.A surgical delay of 90 minutes was reported.No patient complications were reported.
 
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Brand Name
INCORE LAPIDUS SYSTEM
Common Device Name
SCREW
Manufacturer (Section D)
NEXTREMITY SOLUTIONS
210 north buffalo street
warsaw IN 46580
MDR Report Key8895079
Report Number3009540749-2019-00007
Device Sequence Number2361793
Product Code HWC
UDI-Device Identifier00817701020905
UDI-Public00817701020905
Combination Product (Y/N)N
Initial Reporter StateHI
Initial Reporter CountryUS
PMA/510(K) Number
K180257
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2079
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model NumberIC-LAP-5928RP
Device Lot NumberR18246
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/15/2019
Initial Report FDA Received Date08/14/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age51 YR
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