MAUDE Adverse Event Report: DEPUY SPINE INC MOSS MIAMI SPINE SYSTEM ROD 5.5 X 40MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 179762040

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

Patient Problem Osteolysis (2377)

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that the patient underwent a plif on (b)(6), 2018.The surgery was completed successfully without any delay.On (b)(6), 2022, an extension to the upper vertebral body revision plif was scheduled to be performed because the patient developed an adjacent intervertebral disorder.No further information is available.This report involves one moss miami spine system rod 5.5 x 40mm.This is report 12 of 12 for (b)(4).

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 its employees caused or contributed to the potential event described in this report.Additional narrative: additional device product codes: kwp, kwq.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility name: (b)(6).Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

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 its employees caused or contributed to the potential event described in this report.H4 a review of the receiving inspection (ri) for mmsi rod, 5.5 x 40mm, ti was conducted identifying that lot number bdi84sg was released in one batch batch1: lot qty of (b)(4) units were released on 13 oct, 2015 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Product was not returned.Based on the information available, it has been determined that no corrective and 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 if information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MOSS MIAMI SPINE SYSTEM ROD 5.5 X 40MM
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16078337
• MDR Text Key: 306436294
• Report Number: 1526439-2022-02243
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 179762040
• Device Catalogue Number: 179762040
• Device Lot Number: BDI84SG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 TI CORT FIX 7X45MM; 5.5 TI CORT FIX 7X45MM; 5.5 TI CORT FIX 7X50MM; 5.5 TI CORT FIX 7X50MM; CONCORDE BUL PAR 9X7X23; CONCORDE BUL PAR 9X7X23; MMSI ROD, 5.5 X 40MM, TI; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW
• Patient Outcome(s): Required Intervention