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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ORTHOLOCK EX-PIN 3 X 110; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ORTHOLOCK EX-PIN 3 X 110; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6007103110
Device Problem Fracture (1260)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2020
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility, while inserting the ortholock pin, the tip of the pin broke off in patients tibia.A second ortholock pin was used to complete the procedure.The surgeon made the decision to leave the first pin in the bone.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results h3 other text : no product return per the customer.
 
Event Description
It was reported that during a procedure at the user facility, while inserting the ortholock pin, the tip of the pin broke off in patients tibia.A second ortholock pin was used to complete the procedure.The surgeon made the decision to leave the first pin in the bone.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
ORTHOLOCK EX-PIN 3 X 110
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key11570703
MDR Text Key242291439
Report Number3015967359-2021-00268
Device Sequence Number1
Product Code HAW
UDI-Device Identifier54546540503225
UDI-Public54546540503225
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6007103110
Device Lot NumberNOT REPORTED
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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