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

Catalog Number 04.607.402S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Additional product codes: mni, mnh, kwp, kwq.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported a procedure for adolescent idiopathic scoliosis (ais) at t2 ¿ l1 was performed on (b)(6) 2017 utilizing the universal spine system ii.During final tightening, the 12 point nut became cross-threaded.Surgeon attempted to loosen the nut which resulted in the polyaxial head for uss polyaxial screw to break.The broken polyaxial head was removed and the rod was shifted.A new polyaxial head was used to complete the procedure.Surgery was delayed approximately 15 minutes with no adverse consequence to the patient.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Date of this report reported incorrectly on initial mw.The correct date is november 29, 2017.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation, as part was discarded by the facility.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

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7153317
• MDR Text Key: 96233133
• Report Number: 8030965-2017-50994
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819950337
• UDI-Public: (01)07611819950337(17)EXPIRATIONUNKNOWN(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.607.402S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1