MAUDE Adverse Event Report: WARSAW ORTHOPEDICS TSRH SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number GX83565509

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Numbness (2415); No Code Available (3191)

Event Date 07/22/2016

Event Type  Injury  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # 83565509, 510k #k090740 was cleared in the united states.(b)(4).Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

It was reported that the patient underwent posterior lumbar fusion (plf) surgery at l5-s1 level, for the treatment of spondylolisthesis.During surgery, a pedicle screw deviated from l5.Reportedly, there was a delay of more than 60 min as a result of this event.Post-op, patient reported numbness in lower limbs.Revision surgery had to be performed on an unknown date to reinsert the deviated pedicle screw.Reportedly, after re-insertion of the pedicle screw, it is expected that patient's pain will disappear.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: TSRH SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5899578
• MDR Text Key: 52831628
• Report Number: 1030489-2016-02410
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

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 Catalogue Number: GX83565509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/24/2016
• Supplement Dates Manufacturer Received: 07/26/2016
• Supplement Dates FDA Received: 09/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention