SILICONE PIP SZ. 2 SPIP-520-2-WW

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-03-26 for SILICONE PIP SZ. 2 SPIP-520-2-WW manufactured by Ascension Orthopedics.

Event Text Entries

[103465285] The product was not returned for evaluation. Review of manufacturing records showed no evidence of a nonconformance that may have caused or contributed to the reported event. Based on the information received to date, the root cause cannot be determined nor can the failure be confirmed. The initial report states that the patient was flicking a book page, and the relationship of this event to the break cannot be determined. Outside of patient trauma, an improperly seated implant leading to additional stress on the hinge may have caused or contributed to the event.
Patient Sequence No: 1, Text Type: N, H10


[103465286] It was reported that a spip-520-2-ww silicone pip implant broke. In (b)(6) 2016, a pip j replacement in the index finger was performed with a spip-520-2-ww silicone pip implant. In (b)(6) 2018, 17 months post implantation, the implant broke while the patient was flicking the page of a book. No specific trauma or contributing events prior to the discovery of the issue. Subsequently, the implanted product was explanted and was replaced with another of the same size. No further patient complications were reported and the patient was doing well after the procedure. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1651501-2018-00022
MDR Report Key7370698
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-03-26
Date of Report2018-03-15
Date Mfgr Received2018-06-21
Date Added to Maude2018-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTAL HYGIENIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER VIVIAN NELSON
Manufacturer Street105 MORGAN LANE
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 NameSILICONE PIP SZ. 2
Generic NameSILICONE PIP
Product CodeKYJ
Date Received2018-03-26
Returned To Mfg2018-04-23
Catalog NumberSPIP-520-2-WW
Lot Number151016T
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
101. Required No Informationntervention 2018-03-26

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