MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL SPACER 10MM X 28MM 10MM HEIGHT STERILE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 08.812.010S

Device Problem Mechanical Jam (2983)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 09/23/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient weight was not provided by reporter.It is unknown if the complained device was implanted in the patient.It is unknown if the complaint device is expected for return to synthes for evaluation.(b)(6).Additional surgical intervention.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review has been requested.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 (b)(4) reported an event italy as follows: it was reported that during a spinal arthrodesis procedure the t-pal spacer applicator could not be detached from the cage which was already inserted inside the patient.It was reported by the surgeon that all the steps were performed as described on the device surgical sheet.The applicator instrument was deliberately broken off to allow for the release of the cage.This event resulted in a 30 minute surgical delay.There was no report of patient harm and the surgery was completed without further complications.This report is 4 of 4 for (b)(4).

Manufacturer Narrative

Additional narrative: device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 03.June 2015, expiry date: 01.May 2025, no anomalies were detected during device history record review.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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: T-PAL SPACER 10MM X 28MM 10MM HEIGHT STERILE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5133717
• MDR Text Key: 27769515
• Report Number: 3003875359-2015-10433
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.812.010S
• Device Lot Number: 9474938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR