MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Model Number 04.617.814

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information not available for reporting (b)(4), lot number unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in (b)(6) as follows: it was reported during an unknown surgical procedure on (b)(6) 2018, three (3) separate 3.0mm cervical spine locking screws chipped during the torquing stage.No fragments were generated.The screws were replaced with new screws, surgery was completed with no further issues.This report is for one (1) 3.0mm cervical spine locking screw.(b)(4).

• Brand Name: 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7329124
• MDR Text Key: 102207224
• Report Number: 2939274-2018-50991
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 10705034742274
• UDI-Public: (01)10705034742274(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K152239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.617.814
• Device Catalogue Number: 04.617.814
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2018
• 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