MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - SCREWS: EXPEDIUM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Device-Device Incompatibility (2919)

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

Event Date 07/24/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in japan as follows: it was reported that this was an unknown surgery for ais (type2) performed on (b)(6) 2023.After setting rods, the surgeon used the compressor for leveling the vertebral body, but the compressor was difficult to apply force therefore competitor¿s compressor which the surgeon has been familiar to use for setting the verse system and altalyne rods was used.A phenomenon occurred in which the verse system and altalyne rods moved even though the surgeon applied a strong compression and the assistant surgeon made the final tightening.Therefore, the surgeon become enraged that the verse system might be systemically problematic in cases such as scoliosis, which requires strong correction.A competitor's device was used in the distraction procedure too and the final tightening was done, but the verse system could not hold the tightened position after the final tightening.The surgeon pointed out the shortcomings of the verse system.To prevent the implants from moving from the position set by the final tightening, the surgeon distributed the stress so that it was not concentrated in one place and managed to complete the procedure.The surgery was completed successfully with no surgical delay.No further information is available.This report is for unk - screws: expedium.This is report 2 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2, d3, d4, g4-510k: this report is for an unknown screws: expedium/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.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.

• Brand Name: UNK - SCREWS: EXPEDIUM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 17476106
• MDR Text Key: 320673352
• Report Number: 1526439-2023-01442
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2023
• 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: UNK - RODS: SPINE; XPDM COMPRESSOR, PARALLEL