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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS HEADLESS SCREW SZ. 2.5MM X 18MM; CAPTURE
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ASCENSION ORTHOPEDICS HEADLESS SCREW SZ. 2.5MM X 18MM; CAPTURE Back to Search Results
Catalog Number AH2518
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported that 2 different type of screws broke off in patient while in use.It is unknown if there was patient injury or if the event led to surgical delay.Additional information has been requested.
 
Manufacturer Narrative
The screws were not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
Event Description
N/a.
 
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Brand Name
HEADLESS SCREW SZ. 2.5MM X 18MM
Type of Device
CAPTURE
Manufacturer (Section D)
ASCENSION ORTHOPEDICS
8700 cameron road #100
8700 cameron road #100
austin TX 78754
MDR Report Key10876931
MDR Text Key250998644
Report Number1651501-2020-00019
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
PMA/PMN Number
K092440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAH2518
Was Device Available for Evaluation? No
Date Manufacturer Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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