MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 LORDOTIC ROD-45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	186788045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The viper 2 lordotic rod was received with the rod assembled onto the screw.A portion of the rod was broken off and not returned.This is consistent with the reported complaint condition, thus confirming the complaint.A manufacturing record review could not be performed as the lot number is unknown.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.
Event or Problem Description
On (b)(6) 2017, an initial tlif (transforaminal lumbar interbody fusion) procedure was performed to stabilize l4-5 at a different hospital.On (b)(6) 2019, the surgeon performed a tlif revision procedure and a pps (percutaneous pedicle screw) extension procedure to treat spinal stenosis, stabilizing l5-s1.The poly driver (279734000) broke off against the highly ossified bone.The surgeon removed the fragment and a screw and completed the procedure with replacements less than a 30-minute delay.No further information is available.This complaint involves one (1) device.

• Brand Name: VIPER2 LORDOTIC ROD-45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9314687
• Report Number: 1526439-2019-52404
• Device Sequence Number: 11390296
• Product Code: NKB
• UDI-Device Identifier: 10705034131740
• UDI-Public: 10705034131740
• Combination Product (Y/N): N
• PMA/510(K) Number: K071860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 186788045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1