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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC SI POLYAXL SCREW 5 X 45MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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DEPUY SPINE INC SI POLYAXL SCREW 5 X 45MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 179712545
Device Problems Break (1069); Entrapment of Device (1212); Migration (4003)
Patient Problems Pain (1994); Foreign Body In Patient (2687)
Event Type  Injury  
Event Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 the patient underwent a lumbar fusion with pedicle screw fixation using the depuy expendium polyaxial synthes screw. The patient experienced severe back pain and it was discovered that the screw had been cut inside the patient. A revision operation was performed on (b)(6) 2021 where part of the screw was removed. The other part of the screw remains inside patient's body. This report is for (1) expedium spine system si polyaxial screw 5. 5 x 5 x 45mm. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameSI POLYAXL SCREW 5 X 45MM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC)
50461 west pontiac trail
wixom MI 48393
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key12786882
MDR Text Key280586391
Report Number1526439-2021-02365
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034067568
UDI-Public10705034067568
Combination Product (y/n)N
Reporter Country CodeCY
PMA/PMN Number
K160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number179712545
Device Catalogue Number179712545
Device Lot NumberAPDBNF
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2013
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/10/2021 Patient Sequence Number: 1
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