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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US ACP 1 VARIABLE SELF TAPPING BONE SCREW SET DIA 4.0X14MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
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STRYKER SPINE-US ACP 1 VARIABLE SELF TAPPING BONE SCREW SET DIA 4.0X14MM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS. Back to Search Results
Model Number 48804414A
Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)
Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Event Date 06/28/2017
Event Type  malfunction  
Event Description
It was reported that during insertion the threaded portion of the locking mechanism broke off in the plate.Surgeon decided against removing the screws and replacing plate (per rep's suggestion).Threaded portion is stuck in the plate inside the patient.Other piece of the locking mechanism will be returned.
 
Manufacturer Narrative
Method: visual inspection, functional inspection, device history review, complaint history review, risk assessment.The customer reported event was confirmed via visual inspection.The device was found to be fractured.Manufacturing history was reviewed and no issues were identified.A root cause of the event was determined to be excessive torsional force applied to the locking screw during insertion.
 
Event Description
It was reported that during insertion the threaded portion of the locking mechanism broke off in the plate.Surgeon decided against removing the screws and replacing plate (per rep's suggestion).Threaded portion is stuck in the plate inside the patient.Other piece of the locking mechanism will be returned.
 
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Brand Name
ACP 1 VARIABLE SELF TAPPING BONE SCREW SET DIA 4.0X14MM
Type of Device
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS.
Manufacturer (Section D)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer (Section G)
STRYKER SPINE-US
2 pearl court
allendale NJ 07401
Manufacturer Contact
marta koutsogiannis
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key6737554
MDR Text Key80946785
Report Number3004024955-2017-00031
Device Sequence Number1
Product Code KWQ
UDI-Device Identifier07613327122275
UDI-Public(01)07613327122275
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number48804414A
Device Catalogue Number48804414A
Device Lot NumberM62699
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/28/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age51 YR
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