MAUDE Adverse Event Report: SYNTHES MONUMENT 5.0MM COATED ROD TEMPLATE 500MM

Catalog Number 388.907

Device Problem Incorrect Measurement (1383)

Patient Problem Sedation (2368)

Event Date 06/02/2015

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that an x-tab was applied in order to denature a scoliosis patient at the region of th10-sai.During the procedure, the surgeon contoured and cut a rod implant utilizing the rod template, but found that the template measurements were inaccurate.When the surgeon attempted to insert the pre-cut rod, it was too short.Another rod was contoured and the surgeon proceeded with the surgery.A delay of forty (40) minutes was noted.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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

Additional narrative: product investigation evaluation: the event was determined to have been the result of off label use: the trial rod of synthes spine system has been combined with rods (implants) from the depuy spine system.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

Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: tecomet ¿ (b)(4)manufactured the 5.0mm coated rod template, 500mm, p/n 388.907, lot # 7008300, per (b)(4), dated october 18, 2012, for (b)(4) parts.The lot was inspected and conformed to (b)(4).There were no mrrs, ncrs, or complaint-related issues for this lot.70 parts were released to the warehouse on october 23, 2012.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: 5.0MM COATED ROD TEMPLATE 500MM
• Type of Device: TEMPLATE
• 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: 4844642
• MDR Text Key: 5934224
• Report Number: 2520274-2015-14456
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.907
• Device Lot Number: 7008300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 06/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/02/2015; 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention