MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SFX,5.5,TI, MED, SIZE A5; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 189401405

Device Problem Material Integrity Problem (2978)

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

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: additional device product codes: kwq, osh, mni, mnh, kwp.A product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that one of the set screws of the sfx,5.5,ti, med, size a5 was completely stripped.The device was received assembled with an unknown rod which cannot be removed as the set screw is stripped.No other issues were identified with the device.The dimensional inspection was not performed due to the post manufacturing damage.The observed condition of the sfx,5.5,ti, med, size a5 was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.A functional test could not be performed as the set screw was stripped and could not be removed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the sfx,5.5,ti, med, size a5 was observed to have a set screw in the stripped condition.While no definitive root cause could be determined from the available information, it is probable that the set screw of the sfx,5.5,ti, med, size a5 was stripped due to exposure to excessive/unintended forces.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.A review of the receiving inspection (ri) for sfx,5.5,ti, med, size a5 was conducted identifying that lot number om11258 was released in a single batch.Batch1: lot qty of (b)(4) units were released on feb 3, 2021 with no discrepancies.Batch2: lot qty of (b)(4) units were released on apr 23, 2021 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.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 depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during a procedure, the transverse system locking nut was damaged while tightening and it was impossible to unscrew it.The surgeon had to use another transversal liaison and change the screws.There was a thirty (30) minutes surgical delay.No further information provided.This report is for one (1) sfx,5.5,ti, med, size a5 this is report 1 of 1 for complaint (b)(4).

• Brand Name: SFX,5.5,TI, MED, SIZE A5
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13726265
• MDR Text Key: 288035536
• Report Number: 1526439-2022-00391
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034168128
• UDI-Public: (01)10705034168128
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142460
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 189401405
• Device Catalogue Number: 189401405
• Device Lot Number: OM11258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1