MAUDE Adverse Event Report: SYNTHES MEZZOVICO 4.5MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 04.613.564S

Device Problem Fitting Problem (2183)

Patient Problem Sedation (2368)

Event Date 05/18/2015

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a surgeon experienced difficulty inserting a screw into the screw-hole of a plate during a surgical procedure on (b)(6) 2015.The surgeon attempted to insert the screw using several positions and several screws (of differing length/thickness), but the issue was not resolved.Ultimately, the surgeon opted to use another plate with longer length in order to complete the procedure.A sixty (60) minute delay was noted.Following the procedure, the washer of the original plate was found to be malformed/bent.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Additional narrative: patient identifier and weight are unknown.Device was not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history review: manufacturing location: (b)(4) - manufacturing date: february 6, 2008 - expiry date: february 1, 2018.No non-conformance reports 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.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.

Manufacturer Narrative

A manufacturing evaluation was completed: two screws have been received not in the original packaging.The screws are damaged post production.The returned screws have been re-inspected for all the features relevant to the failure mode notified.The conclusion of the re-inspection is that the products are conforming from a manufacturing perspective.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

There were reinsertions of screw several times, which made a screw hole wider and also unnecessary hole.

Manufacturer Narrative

A manufacturing investigation action/summary was conducted/performed.The report indicates that we have received those three articles for investigation and forwarded them to the manufacturing plant; here the feedback: the plate has been returned not in the original packaging.The clips in two holes are visual damaged post production.The returned plate and the two screws have been re-inspected for all the features relevant to the failure mode notified.The report indicates that the: art: 04.613.564s / 04.613.566s, two screws have been received not in the original packaging.The screws are damaged post production.The conclusion of the re-inspection is that the products are conforming from a manufacturing perspective.Dhr review showed conformity to the specifications.The plate was manufactured in june 2014, screw 04.613.564s manufactured in february 2008 and screw 04.613.566s in april 2014.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: 4.5MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 14MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4824946
• MDR Text Key: 5841669
• Report Number: 1000562954-2015-10123
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK071667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Catalogue Number: 04.613.564S
• Device Lot Number: 1835930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR