MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE CAN SCR 5.0X45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 199725545S

Device Problem Device Slipped (1584)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Additional procode: kwp; kwq; mnh; mni; osh.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the primary posterior lumbar interbody fusion (plif) at l4/5 was performed on the patient.On an unknown date, it was found that the patient had suffered from restenosis.On (b)(6) 2021 the patient underwent a plif revision procedure treating the restenosis.During the revision procedure, the surgeon found the loose screw which was replaced with a new one.No further information is available.Concomitant device reported: unknown rods (part # unknown, lot # unknown, quantity unknown), unknown set screws (part # unknown, lot # unknown, quantity unknown ), unknown cage (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 5.5 exp verse can scr 5.0x45.This is report 2 of 4 for (b)(4).

• Brand Name: 5.5 EXP VERSE CAN SCR 5.0X45
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12226294
• MDR Text Key: 263471740
• Report Number: 1526439-2021-01520
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142185
• 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: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199725545S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention