MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE FEN SCR 7.0X30; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 199723730S

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional product code: kwp, kwq.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot the dhr of product code: 199723730s, lot : 306959 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 09.04.2021, qty:(b)(4).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 on an unknown date that the patient had started feeling paint in left buttock postoperatively.The patient underwent for a surgery to treat of the primary posterior thoracolumbar fusion (t12-s1) due to l3 fracture on (b)(6) 2021.There was no further surgery schedule reported.The patient outcome unknown.This complaint involves one device.This report is for (1) 5.5 exp verse fen scr 7.0x30 this report is 1 of 1 for (b)(4).Related product complaint: (b)(4).

• Brand Name: 5.5 EXP VERSE FEN SCR 7.0X30
• 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: 12325515
• MDR Text Key: 266696127
• Report Number: 1526439-2021-01703
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034444536
• UDI-Public: 10705034444536
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173095
• 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: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199723730S
• Device Catalogue Number: 199723730S
• Device Lot Number: 306959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR