Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. PIP SZ. 30 PROXIMAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ASCENSION ORTHOPEDICS, INC. PIP SZ. 30 PROXIMAL Back to Search Results
Catalog Number PIP-200-30P-WW
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
It was reported.The proximal part (of a pip implant) broke 3 to 4 weeks after the implantation.The surgeon did not observe anything that could explains this breakage.No trauma after the implantation.Date of first surgery was on (b)(6) 2014.The device was removed on (b)(6) 2014.Another implant was implanted.Photos of the implant were provided.Additional info was requested by integra.
 
Manufacturer Narrative
To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported info.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PIP SZ. 30 PROXIMAL
Type of Device
PIP
Manufacturer (Section D)
ASCENSION ORTHOPEDICS, INC.
austin TX 78754
Manufacturer Contact
caren finkelstein
315 enterprise dr.
plainsboro, NJ 08536
6099362341
MDR Report Key3708438
MDR Text Key20781609
Report Number1651501-2014-00016
Device Sequence Number1
Product Code MPK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
H010005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPIP-200-30P-WW
Device Lot Number13-0636
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/25/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-