MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI CERV SPINE LOCKING PLATE 24MM (16MM); APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 450.116

Device Problem Material Integrity Problem (2978)

Patient Problem Non-union Bone Fracture (2369)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Part # 450.116-us, lot # 23p9644, manufacturing site: (b)(4), release to warehouse date: december 11, 2019.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The implant(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed, and the complaint condition could be confirmed as the x-ray shows a broken locking plate.As the implant(s) was not returned in as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.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.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

It was reported that on (b)(6) 2021, the patient underwent a revision surgery for a broken plate.On (b)(6) 2020, due to a traumatic injury, the patient had an anterior cervical fusion at c5-c6 using a cslp plate.During a routine follow-up visit on (b)(6) 2021, the surgeon discovered that the plate had broken when viewing on a standard follow-up x-ray.The surgeon performed the revision surgery on (b)(6) 2021.The surgeon confirmed that the patient has a non-union at the c5-c6 level.During the revision, he removed the broken cslp plate.The expansion head screws and locking screws were also completely removed and no fragments/parts remain in the patient.One the entire cslp construct was removed.The surgeon flipped that patient prone and did a c5-c6 posterior cervical fusion using the depuy synthes spine symphony system.The procedure was successfully completed.This report involves one (1) ti cervical spine locking plate 24mm (16mm).This is report 1 of 1 for (b)(4).

• Brand Name: TI CERV SPINE LOCKING PLATE 24MM (16MM)
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11797332
• MDR Text Key: 249711139
• Report Number: 2939274-2021-02273
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10705034780504
• UDI-Public: (01)10705034780504
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 450.116
• Device Catalogue Number: 450.116
• Device Lot Number: 23P9644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1.8MM TI LOCKING SCREW; 1.8MM TI LOCKING SCREW; 1.8MM TI LOCKING SCREW; 1.8MM TI LOCKING SCREW; 4.35MM TI CANC EXP HD SCR/SLF-TAP/16MM; 4.35MM TI CANC EXP HD SCR/SLF-TAP/16MM; 4.35MM TI CANC EXP HD SCR/SLF-TAP/16MM; 4.35MM TI CANC EXP HD SCR/SLF-TAP/16MM
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR