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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC CONN O/O SD TOP NTCH 5.5X5.5 T; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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DEPUY SPINE INC CONN O/O SD TOP NTCH 5.5X5.5 T; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 179771555
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/23/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4), unknown.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
It was reported that the posterior spine fusion surgery was performed on (b)(6) 2019 due to thoracic lumbar spinal canal stenosis after olif to fix th9/sai with expedium system.In order to do the reinforcement of fixation, the surgeon choose double rod technique with re bend rod and universal connector (p/n: 179771555) from lumbar to sai.However, the surgeon felt strange feeling when the surgeon performed final tightening of the set screw, so that the surgeon removed the set screw.Then, it was reported that the surgeon recognized that the there was a cross thread at the set screw.Thus, the surgeon replaced the set screw and universal connector, and was able to complete the surgery.There was no broken fragment in the patient¿s body.There was less than 30 min.Surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.
 
Manufacturer Narrative
Product complaint #
=
> (b)(4).Visual examination found that the initial thread on the connector were torn.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head of the connector.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.With the information provided, a definitive root cause for the torn threads on the conn o/o sd top ntch 5.5x5.5 t cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head of the connector.It should be noted that tightening the setscrew when it is cross threaded places force on the setscrew and the tulip head¿s threads that can result in them being torn.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, 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
CONN O/O SD TOP NTCH 5.5X5.5 T
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)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8689825
MDR Text Key147730546
Report Number1526439-2019-51749
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034077819
UDI-Public(01)10705034077819
Combination Product (y/n)N
PMA/PMN Number
K160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number179771555
Device Catalogue Number179771555
Device Lot NumberNW226086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/22/2019
Initial Date FDA Received06/11/2019
Supplement Dates Manufacturer Received07/12/2019
Supplement Dates FDA Received07/15/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/31/2018
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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