MAUDE Adverse Event Report: SYNTHES MEZZOVICO TI POLYAXIAL HEAD FOR USS POLYAXIAL; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.607.402

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Device was not implanted/explanted.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).Manufacturing date: march 21, 2007.This article consists of two components (body and ring).No non-conformance reports were generated during production.Review of the device history records 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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: the locking ring, should be attached to the 3d head, but it was separated.This was noticed during the cleaning and sterilization cycle.Implant was removed from set.It appears that the locking ring is smaller than other items within the same article number.There was no patient/surgery involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

A manufacturing evaluation was completed: part received not in the original not sterile packaging.Part is disassembled in the two components.The two components have been re-inspected for all the features pertinent to the complaint condition with the conclusion that all relevant measurable features meet specification.Two relevant features cannot be measured because they are damaged by assembling process (features not measurable after assembling).This complaint is disposed as confirmed due to the fact the returned item is disassembled.Considering that it was not possible to re-inspect all the relevant features the issue is considered indeterminate.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The involved part has been assembled in 2007 according to the procedure which requires that after assembling the operator verifies that the body can rotate within the locking-ring and that the two components do not disassemble.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 POLYAXIAL HEAD FOR USS POLYAXIAL
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 5060560
• MDR Text Key: 25176062
• Report Number: 1000562954-2015-10179
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.607.402
• Device Lot Number: 1659869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1