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 from a company representative,distri report with the FDA on 2015-12-21 for MCP SZ. 30 PROXIMAL WW MCP-100-30P-WW manufactured by Ascension Orthopedics.

Event Text Entries

[34047468] Integra has completed their internal investigation on 16dec2015. The investigation included: methods: review of device history records. Review of complaint history. Results: (b)(4). Conclusion: the implants or trials were not returned; therefore, a root cause could not be identified at this time.
Patient Sequence No: 1, Text Type: N, H10


[34047469] It was reported there was a discrepancy with size of trials vs size of implant devices. When the set was returned to the distributor, the hospital indicated that the trial implants are smaller than the real implant (same size indicated but different size in reality). The hospital thought that trial implants are perhaps used. When the set was received, the distributor checked the trial implants. They are correct not damaged and not broken. The distributor thought that perhaps the "real" implanted implants have not the correct size/dimensions. It was later reported that the surgery could be finished. The surgeon had difficulties regarding the difference between size of final implants and trial implants. The patient was not directly impacted by this matter but the surgeon had to adapt to the issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1651501-2015-00046
MDR Report Key5316352
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2015-12-21
Date of Report2015-11-26
Date Mfgr Received2015-11-26
Device Manufacturer Date2014-11-24
Date Added to Maude2015-12-21
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 MARIA LEONARD
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 Report3

Device Details

Brand NameMCP SZ. 30 PROXIMAL WW
Generic NameMCP
Product CodeNEG
Date Received2015-12-21
Catalog NumberMCP-100-30P-WW
Lot Number142650T
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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 2015-12-21

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