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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO UNKNOWN_INSTRUMENTSTIRE_PRODUCT ARTHROSCOPE

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STRYKER INSTRUMENTS-PUERTO RICO UNKNOWN_INSTRUMENTSTIRE_PRODUCT ARTHROSCOPE Back to Search Results
Catalog Number UNK_IPR
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/11/2011
Event Type  Injury  
Manufacturer Narrative
Product not being returned.
 
Event Description
It was reported that a metal piece of the device broke off during a discectomy procedure in 2011. The metal was confirmed to be in the patient's neck after the patient underwent mri testing in 2014 due to unrelated injuries from an auto accident. It was further reported that the patient was advised to temporarily delay the surgical removal of the metal until the disc deteriorates more.
 
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Brand NameUNKNOWN_INSTRUMENTSTIRE_PRODUCT
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6015290
MDR Text Key56914065
Report Number0001811755-2016-02543
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 09/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_IPR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2016
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 Initial

Patient Treatment Data
Date Received: 10/10/2016 Patient Sequence Number: 1
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