MAUDE Adverse Event Report: SYNTHES MONUMENT TI CRANIAL FLAP TUBE CLAMP TEXTURED 13MM DIA-STERILE; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number 460.008.01S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient was having a problem with a titanium mesh plate.In 2007, the patient underwent a cranioplasty and had an unknown titanium mesh plate implanted along with unknown screws and norian bone putty.Titanium cranial flap tube clamps (textured) were used.The patient complained to surgeon that the area was very sensitive.She indicated that she could feel the implant and was experiencing pain.The plate remained implanted until (b)(6) 2015 at which time the plate and screws were removed due to the plate protruding through the skin.After explantation, bacteria was found on the plate.The patient is now being treated with a course of antibiotics.There is not additional information available for this complaint.This report is 4 of 7 for (b)(4).

Manufacturer Narrative

Patient weight is unknown.Onset date of pain and infection is unknown.Implant date: unknown date in 2007.The investigation could not be completed; no conclusion could be drawn as no product was received.A review of the device history records has been requested and is pending completion.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

Device was used for treatment, not diagnosis.A device history record (dhr) review was performed for the subject device lot number 4737485.The review revealed that the work order (wo) was issued for the following operations: generate label, prep order, seal order, box order, ship order, vendor sterilize, and release to warehouse (dated march 24, 2004), part expiration date (02/28/2013).The lot was split from lot number 4730038 and a separate wo number due to repack sterile.An mrr was written on march 02, 2004 for: parts were exposed to water damage during transport.All shippers are water logged.¿ the mrb disposition was rework and split to new work order to repackage.The mrr was closed on march 02, 2004.The bp 20 lot number 4673967 indicated the titanium cranial flap tube clamp, textured 13mm diameter, 100 part lot, was manufactured by spectrum manufacturing, per p/n 460.008.The certificate of compliance indicated the lot was manufactured and conformed to specifications.The lot was inspected and conformed to the synthes incoming final inspection sheet.The titanium cranial flap tube clamp, textured 13mm diameter was manufactured to the synthes product drawing.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Date reported as july 23, 2015 rather than june 23, 2015.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.

Manufacturer Narrative

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

Further information reported that: within the maude report for the complaint the event date is listed as (b)(6), 2007, however, reporter confirmed the event date as (b)(6), 2007.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received from the patient/reporter on (b)(6) 2015.The patient reported that the hardware was originally implanted on (b)(6) 2007.The patient stated that sixteen screws were also implanted on this date.During explant surgery on (b)(6) 2015, the surgeon opted to leave one of the screws implanted due to difficulties explanting it.The remaining 15 screws and previously reported hardware were successfully explanted.The patient also provided the part number for the titanium mesh plate.The plate quantity was confirmed to be one.

• Brand Name: TI CRANIAL FLAP TUBE CLAMP TEXTURED 13MM DIA-STERILE
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4755202
• MDR Text Key: 17936798
• Report Number: 1719045-2015-10274
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK992000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 460.008.01S
• Device Lot Number: 4737485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2004
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR