MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, 480 MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179762480

Device Problem Migration (4003)

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

Event Type  Injury  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that, on (b)(6) 2020 the patient underwent the primary procedure in the sacrum and the ilium for treating asd with the screws in question that were inserted from the sacrum into the ilium and deployed on both sides.The screws in question were supposed to function as anchors for correcting the pelvis.On an unknown date it was found that the screws had come off.A setscrew had come off the screw, and a rod had come off the screw on one side.On the other side, a setscrew had been tightened to the screw, but the rod had come off the screw.The patient is scheduled to undergo a removal procedure in the 1st week of (b)(6) 2022.This report is for one (1) rod, 480 mm.This is report 6 of 6 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.D10: therapy date: june 13, 2020.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.H3, h6: a manufacturing record evaluation was performed for the finished device, product code: 179762480, lot number: bdmv7vb.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: november 30, 2018.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the rod, 480 mm was bent and nicked indicating signs of use which would not contribute to the reported complaint condition.The reported complaint condition of the migration of the implants cannot be confirmed as no post operative radiographic images were provided.A dimensional inspection for rod, 480 mm was conducted and it met specification.A functional test to assess migration of the impacted product could not be conducted as the device was explanted.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 observed condition of the rod, 480 mm would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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: ROD, 480 MM
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13908062
• MDR Text Key: 293143810
• Report Number: 1526439-2022-00469
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077437
• UDI-Public: (01)10705034077437
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179762480
• Device Catalogue Number: 179762480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 04/04/2022; 05/03/2022
• Supplement Dates FDA Received: 05/03/2022; 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 TI CORT FIX 4.35X25MM.; 5.5 TI CORT FIX 8X40MM.; ROD, 480 MM.; ROD, 480 MM.; SI POLYAXL EXT TAB 5 X 30MM.; SI POLYAXL EXT TAB 5 X 35MM.; SI POLYAXL EXT TAB 6 X 35MM.; SI POLYAXL EXT TAB 6 X 45MM.; SI POLYAXL EXT TAB 7 X 35MM.; SI POLYAXL EXT TAB 7 X 40MM.; SI POLYAXL EXT TAB 7 X 45MM.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; UNKNOWN LOCKING/SET SCREWS.; UNKNOWN LOCKING/SET SCREWS.; VIPER TI SAI POLY 8X70MM; VIPER TI SAI POLY 8X70MM.; VIPER TI SAI POLY 8X70MM.; VIPER TI SAI POLY 8X70MM..
• Patient Outcome(s): Required Intervention