MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179704890

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation will be conducted.A follow up will be filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On (b)(6) 2017, surgery for vertebral osteomyelitis was performed using the expedium viper system.The fixed area was l2 ¿ s2.During the surgery, the surgeon confirmed the following issues.He tried to tighten the screw (part#:179704890, lot#: tbfnl) with a driver (part# & lot#: unk).He heard the screw span at the time of tightening.He decided to replace it with a new screw because he felt that the head of screw might be a bit stripped.The surgery was successfully completed with a 5-minute delay, and there was no adverse consequence to the patient.After the surgery, the surgeon and our sales rep confirmed that inner part of the screw head was stripped.

Manufacturer Narrative

Upon completion of the investigation, it was determined that there was no product problem identified with the returned device.The device did not strip as originally reported.As a result, the complaint is no longer a reportable malfunction.This follow up serves as awareness to the change in reportability of the device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6871761
• MDR Text Key: 86586177
• Report Number: 1526439-2017-10745
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034265742
• UDI-Public: (01)10705034265742
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 179704890
• Device Catalogue Number: 179704890
• Device Lot Number: TBFNL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/18/2017
• Supplement Dates Manufacturer Received: 10/03/2017
• Supplement Dates FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1