MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFEN XTAB 7X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 186770440

Device Problem Disassembly (1168)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Viper prime cortical fix screw disassembled and prevented rod from reducing.This required removal of rod and 2 additional screws to correct the issue.New screws were used.Patient consequence? :yes patient consequence description: additional incision size was needed and approximately 45 min was added to procedure.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.Additional clarification from sales rep: the internal mechanism of the poly feature was no longer where it was supposed to be.The other screw had part of the thread shear off preventing a set screw from engaging.This was noticed after rod removal and attempts to replace set screw were unsuccessful.

Manufacturer Narrative

Product complaint # (b)(4).Visual examination of the viper prime cfxfen xtab 7x40mm has exhibited significant signs of clinical use.The lead thread on the tulip's head is torn and the device exhibits severe indentation marks, consistent with the damage occurred while removing the screw.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the torn threads on the viper prime cfxfen xtab 7x40mm cannot be determined.This damage may have occurred due to cross-threading a set screw upon insertion.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).With the information provided, a definitive root cause for the torn threads on the viper prime cfxfen xtab 7x40mm cannot be determined.However, per the surgical technique guide (stg), the procedural flow after screw insertion goes: rod measurement and delivery, set screw insertion, provisional tightening, final tightening, x-tab removal.Each instrument used in these steps (rod holder, final tightener and tab breaker) has a laser etch band that when aligned with the laser etch band on the x-tabs, visually indicates if the rod and set screw are fully seated in the head.This alignment would not have been possible with the raised saddle (poly cap), and a fully seated set screw should also be confirmed with fluoroscopy, prior to removing the x-tabs.Per the event description, the sheared threads on the screw head was created after rod delivery, set screw tightening, x-tab removal, set screw removal, rod removal, rod replacement and set screw replacement.For standard set screw insertion, reduction threads incorporated into the viper prime implant ensure alignment of the set screw prior to its introduction into the implant head.Any attempts to re-insert the set screw without the presence of the x-tab is not prescribed and can potentially result in damaged threads.

• Brand Name: VIPER PRIME CFXFEN XTAB 7X40MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; chemin-blanc 38; le locle, MA 02400 ; SZ 02400 ; 5088808100
• MDR Report Key: 7342347
• MDR Text Key: 102512647
• Report Number: 1526439-2018-50242
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034509600
• UDI-Public: (01)10705034509600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2018

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
• Device Operator: Health Professional
• Device Model Number: 186770440
• Device Catalogue Number: 186770440
• Device Lot Number: TBSXZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 04/20/2018; 12/18/2018
• Supplement Dates FDA Received: 04/20/2018; 01/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other