MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE CAN SCR 7.0X50; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 199725750S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient underwent the primary tlif (l5/6) procedure for treating both lumbar intervertebral foramen stenosis and lumbar disc hernia on (b)(6) 2021.On (b)(6), the patient underwent a hematoma removal procedure.No further information is available.This complaint involves ten (10) devices.This report is for (1) 5.5 exp verse can scr 7.0x50.This report is 4 of 9 for (b)(4).Related product complaint: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or al event described in this repbut.If the potenmati eves udescrn,ed in vhis report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual analysis of the uploaded images revealed that there was no damage or defects with the 5.5 exp verse can scr 7.0x50.A dimensional inspection was not performed for the 5.5 exp verse can scr 7.0x50 as the device was not returned.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the 5.5 exp verse can scr 7.0x50 was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review - there is no known lot number, therefore a mre cannot be completed.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.

• Brand Name: 5.5 EXP VERSE CAN SCR 7.0X50
• 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 ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13090690
• MDR Text Key: 287555330
• Report Number: 1526439-2021-02649
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 199725750S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• 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
• Treatment: 5.5 EXP VERSE CAN SCR 7.0X40; 5.5 EXP VERSE CAN SCR 7.0X40; 5.5 EXP VERSE CAN SCR 7.0X50; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; MMSI ROD, 5.5 X 55MM, TI; MMSI ROD, 5.5 X 55MM, TI; SFX,5.5,TI, MED, SIZE A5; T-PAL PROTI, 10X10X28 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male