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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NORTHERN DIGITAL INC. NDI PASSIVE MARKER SPHERES REFLECTIVE PASSIVE MARKER SPHERES

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NORTHERN DIGITAL INC. NDI PASSIVE MARKER SPHERES REFLECTIVE PASSIVE MARKER SPHERES Back to Search Results
Model Number 8801071
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/29/2015
Event Type  malfunction  
Manufacturer Narrative
Device discarded by site.
 
Event Description
Clinical specialist reported that during a hip replacement case while reaming, the spheres would come off. There was a minimal delay in the case while getting new spheres. Spheres were discarded by site. No lot number information was recorded by site. This occured at (b)(6) hospital. Customer reported no serious injury/death to patient or users.
 
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Brand NameNDI PASSIVE MARKER SPHERES
Type of DeviceREFLECTIVE PASSIVE MARKER SPHERES
Manufacturer (Section D)
NORTHERN DIGITAL INC.
103 randall drive
waterloo, ontario N2V 1 C5
CA N2V 1C5
Manufacturer (Section G)
IIMAK MEXICANA S. DE R.L. DE C.V.
brecha e99 l15e
parque industrial reynosa
reynosa tam, CP887 80
MX CP88780
Manufacturer Contact
gord wehner
103 randall drive
waterloo, ontario N2V 1-C5
CA   N2V 1C5
8845142
MDR Report Key5431917
MDR Text Key38702680
Report Number3002743211-2016-00001
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 08/31/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8801071
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2015
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?
Type of Device Usage

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