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

Catalog Number GX83565459

Device Problem Malposition of Device (2616)

Patient Problems Muscle Weakness (1967); Pain (1994)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

This part is not approved for use in the us, however a like device with part# 83565459, 510k# k090740 and (b)(4) is approved for sale.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

Pre-op diagnosis: l4 burst fracture procedure: l4: vertebroplasty; l3-5: posterior fusion it was reported that post-op, ct exam revealed screw malposition at l5.Patient suffered with low back pain, lower extremity pain and muscle weakness as a result and underwent a revision on (b)(6) to adjust the positions of the screws.

Manufacturer Narrative

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

Manufacturer Narrative

Although it is unknown which of the devices led to the event, however, we are filing this report for notification purposes.Following devices were involved: part# gx83565459 lot# 0350269w qty 1 similar device 83565459 510k# k090740 (b)(4).Part# gx83565459 lot# 0490544w qty 2 similar device 83565459 510k# k090740 (b)(4).Part# gx83565459 lot# 0361972w qty 1 similar device 83565459 510k# k090740 (b)(4).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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6978955
• MDR Text Key: 90283334
• Report Number: 1030489-2017-02249
• 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,Followup
• Report Date: 11/07/2017

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 Expiration Date: 01/21/2023
• Device Catalogue Number: GX83565459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: 09/27/2017; 11/06/2017
• Supplement Dates FDA Received: 10/26/2017; 11/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2015
• 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
• Treatment: RODS, CONNECTOR, SET SCREWS
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 53