MAUDE Adverse Event Report: DEPUY SPINE INC SFX,5.5,TI, MED, SIZE A6; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 189401406

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

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 reported that on (b)(6) 2020, during a posterior lumbar interbody fusion (plif) at l3-l4 procedure, the surgeon used the driver shaft for tightening the sfx connector.Then, the tip of the driver shaft stripped.The surgeon kept using the device and completed the rest of the procedure without surgical delay.The patient outcome was stable.There is no further information available.This report is for one (1) sfx,5.5,ti, med, size a6.This is report 2 of 2 for (b)(4).

• Brand Name: SFX,5.5,TI, MED, SIZE A6
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10853595
• MDR Text Key: 218685234
• Report Number: 1526439-2020-02213
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034168135
• UDI-Public: (01)10705034168135
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 189401406
• Device Catalogue Number: 189401406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2020
• 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