MAUDE Adverse Event Report: SYNTHES MEZZOVICO TI CERVICAL SPINE LOCKING PL VARIABLE ANGLE 3 LEVEL/48MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Catalog Number 450.172

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

Patient date of birth and weight are not available for reporting.(b)(4).Device was not implanted/explanted.Event occurred during the procedure, new plate was inserted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.Device 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 europe reports an event in (b)(6) as follow: it was reported that patient underwent surgery on (b)(6) 2016.During the surgery, after all four (4) screws were implanted into position; the surgeon realized that the ring was outside of the plate.The ring was removed without problems or additional intervention.Plate had not been bended before.The initial plate was retrieved and a new plate was inserted.Surgery was prolonged by 20 minutes.This report is for one (1) ti cervical spine locking pl variable angle 3 level/48mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: device returned to manufacturer.A device history record review was performed on part # 450.172, lot # 8991917: manufacturing location: (b)(4), manufacturing date: 23.May.2014.No non conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A manufacturing investigation was performed.Plate received in a bag for sterilization.The data etched on the plate match with the data reported in the complaint.One bushing is missing from one hole.According to the inspection sheet after assembling the bushing position is 100% verified through visual inspection and the movement of the bushing inside the hole is 100% verified with a gage.No non-conformance has been documented in the dhr.The returned plate was visually inspected: one bushing is missing; all of the other bushings are present in the holes, no visual defects manufacturing related were noticed.The features pertinent with the complaint condition were measured.The hole where the bushing is missing was fully measured and all the features resulted conforming to specifications.Since the bushing is missing the conformity of the plate cannot be determined.The complaint is confirmed since the bushing is missing but the complaint is not valid since no evidence manufacturing related found.No manufacturing related issue was identified and/or confirmed.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.

• Brand Name: TI CERVICAL SPINE LOCKING PL VARIABLE ANGLE 3 LEVEL/48MM
• Type of Device: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico PA CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5996157
• MDR Text Key: 56358760
• Report Number: 2520274-2016-14783
• Device Sequence Number: 1
• Product Code: KWQ
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 450.172
• Device Lot Number: 8991917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 53 YR