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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE DI SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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DEPUY SPINE INC 5.5 EXP VERSE DI SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 199721000S
Device Problem Torn Material (3024)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Event Date 12/21/2017
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
On (b)(6) 2017, the surgery for lumbar vertebral canal stenosis was performed by using the verse cannulated screw and verse collection keys.The fixed area was l4 ¿ l5.Although the outer torque was fastened after inserting the collection key via the facilitator, a sound which the torque was supposed to be spinning around could not be heard (cross-threaded).The surgeon tried this several times.Because even the inner torque could not be fastened thereafter, the screw was removed and replaced with a new one.The surgery was completed with a 40-minute-delay, and there was no adverse consequence to the patient.
 
Manufacturer Narrative
Product complaint # (b)(4).Visual evaluation of the returned device revealed that the threads on set screw was torn and peeled.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause cannot be positively determined.However, based on the visual evaluation of the returned sample, the possible cause of the defect is the instrument been subjected to unanticipated torsional forces during use or wear and tear over time.This will put more pressure on the threads of the set screw causing it to be torn and peeled.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.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 Name
5.5 EXP VERSE DI SET SCR
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
MEDOS INT SARL
chemin blanc 38
le locle
CH  
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key7205231
MDR Text Key97950899
Report Number1526439-2018-50051
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034466125
UDI-Public10705034466125
Combination Product (y/n)N
PMA/PMN Number
K142185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number199721000S
Device Lot Number144278
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/21/2017
Initial Date FDA Received01/19/2018
Supplement Dates Manufacturer Received02/02/2018
Supplement Dates FDA Received02/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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