MCP SZ. 30 PROXIMAL WW MCP-100-30P-WW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for MCP SZ. 30 PROXIMAL WW MCP-100-30P-WW manufactured by Ascension Orthopedics.

Event Text Entries

[142736843] Dhr for lot: 182735t shows that no nonconformances were generated for this lot. The root cause is unknown as the products have not been returned; however, patient activity is a possible contributing factor.
Patient Sequence No: 1, Text Type: N, H10


[142736844] 2 of 2 reports: other mfg report number: 1651501-2019-00014. A company sales representative reported that on (b)(6) 2018 a pyrocarbon mcp (id: mcp-100-30p-ww / lot 182735t) was implanted and on (b)(6) 2019, it was removed due to breakage. The broken implant was discovered during an outpatient visit. The broken implant was replaced with a competitor device. The patient is fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1651501-2019-00015
MDR Report Key8537442
Date Received2019-04-22
Date of Report2019-04-12
Date Mfgr Received2019-06-25
Date Added to Maude2019-04-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER VIVIAN NELSON
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1ASCENSION ORTHOPEDICS
Manufacturer Street8700 CAMERON ROAD #100
Manufacturer CityAUSTIN TX 78754
Manufacturer CountryUS
Manufacturer Postal Code78754
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMCP SZ. 30 PROXIMAL WW
Generic NameMCP
Product CodeNEG
Date Received2019-04-22
Returned To Mfg2019-06-25
Catalog NumberMCP-100-30P-WW
Lot Number182735T
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASCENSION ORTHOPEDICS
Manufacturer Address8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-22

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