MAUDE Adverse Event Report: DEPUY SPINE INC EXP TI POLY SCREW 7.5MMX30MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179712030

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Additional procode: kwp; kwq; mnh; mni; osh.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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 allegedly reported by the patient's legal counsel that on (b)(6) 2017, a transpedicular screw that was used for spine stabilization has broken causing unspecified injuries which required medical intervention.There is no further information available.Concomitant device reported: unknown rod(part# unknown, lot# unknown, quantity# unknown).Unknown set screw(part# unknown, lot# unknown, quantity# unknown).This report is for one (1) exp ti poly screw 7.5mmx30mm.This is report 1 of 1 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.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: EXP TI POLY SCREW 7.5MMX30MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11619105
• MDR Text Key: 243941502
• Report Number: 1526439-2021-00623
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034066561
• UDI-Public: 10705034066561
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179712030
• Device Catalogue Number: 179712030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREW/ROD CONSTRUCT ACCESSORIES; UNKNOWN LOCKING/SET SCREWS; UNK - SCREW/ROD CONSTRUCT ACCESSORIES; UNKNOWN LOCKING/SET SCREWS
• Patient Outcome(s): Required Intervention