MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 STRAIGHT ROD300MM, COCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 196789300

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: this pc is related to (b)(4) which reports about the screw replacement performed in the revision surgery on (b)(6), 2021.This pc reports about the rod breakage found in the removal surgery on (b)(6), 2023.It was reported that this was a pps (l3-5) for a fracture of l4 on (b)(6), 2021.After the initial surgery, a revision surgery was performed on (b)(6), 2021, and the viper monoaxial screw 7×45 mm inserted into l3 right was replaced with a prime screw 7×45 mm.After the revision surgery, a removal surgery was performed on (b)(6), 2023, because bone union was confirmed.During the removal surgery, it was found that the rod (196789300) that had been installed on the left side was broken just above the screw at l4.The removal of the rod itself was done with no problems.The removal surgery was completed successfully with no surgical delay.There was no impact on the patient due to the rod breakage and no symptoms, etc.The exact date of the rod breakage is unknown.No further information is available.Concomitant device reported - unk - screws: viper (part# unknown, lot# unknown, quantity 1).This report is for one (1) viper2 straight rod300mm, cocr.This is report 1 of 1 for complaint (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.D2b: additional product codes: osh,mnh,mni,kwq, and kwp.E1:federation of national public service personnel mutual aid associations (b)(6) hospital.(b)(6), (b)(6).D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h4, h6 a review of the receiving inspection (ri) for viper2 straight rod300mm, cocr, was conducted identifying that lot number gm55581 was released in one batch.Batch1: lot units were released on jan 28, 2020 with no discrepancies.Supplier : depuy : seabrook medical 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.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: VIPER2 STRAIGHT ROD300MM, COCR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17633819
• MDR Text Key: 322087605
• Report Number: 1526439-2023-01537
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034295251
• UDI-Public: (01)10705034295251
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111136
• 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: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 196789300
• Device Lot Number: GM55581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: VIPER
• Patient Outcome(s): Required Intervention