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

Model Number	199723730S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12325515
• Report Number: 1526439-2021-01703
• Device Sequence Number: 20011815
• Product Code: NKB
• UDI-Device Identifier: 10705034444536
• UDI-Public: 10705034444536
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 199723730S
• Device Catalogue Number: 199723730S
• Device Lot Number: 306959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR