MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 3600315

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a health care provider via a manufacturer representative regarding a spinal therapy.It was reported that surgeon stated the metal is "too soft" and strips too easy.This item was stripped.The torque shaft was used with the set screw.Also surgeon reduced the rod but was unable to engage set screw into screw.He commented that the alignment seems off.There were no patient symptoms reported.There were no further complications reported regarding the event.

• Brand Name: INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10776607
• MDR Text Key: 214314183
• Report Number: 1030489-2020-01563
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00643169541962
• UDI-Public: 00643169541962
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K163375
• 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
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600315
• Device Catalogue Number: 3600315
• Device Lot Number: H5618545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2020
• 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