MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI CERVICAL SPINE LOCKING PL VARIABLE ANGLE 1 LEVEL/16MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Catalog Number 450.152

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Perforation of Esophagus (2399); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes rep.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 reports an event in (b)(6) as follows: it was reported that in post-op breakage, the patient was given accf operation on 7th april.Three days after the operation, it was noted that the screw was protruding from the plate/space's surface and scratched the esophagus.The inner ring of the space detached from the space, the head of screw was broken off.The distributor's staff was on site in the original surgery, saw the screw was cracking.The surgeon decided not remove it on the original surgery.The patient's esophageal was rupture, no serious infection at present.The patient is stable and in hospital now.This complaint was linked to (b)(4) that was created to capture the cervical spine expansion head screw that was cracking during insertion (intra-op) and (b)(4) that was originally created that captures the post-op event.This complaint involves two (2) devices this report is 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part: 450.152, lot: 2l27766, manufacturing site: mezzovico, release to warehouse date: november 14, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Complaint is confirmed as we are able to confirm complaint description (broken) based on the received pictures.Product was not returned therefore no further investigation possible.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available (information or/and material), the investigation will be updated as applicable.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

Concomitant devices reported: locking screw (part number unknown, lot unknown, quantity unknown), cervical spine expansion head screw (part number unknown, lot unknown, quantity unknown), 4.0mm ti cortex expansionhead screw self-drilling 16mm (part number 450.139, lot 3l45602, quantity 1).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 CERVICAL SPINE LOCKING PL VARIABLE ANGLE 1 LEVEL/16MM
• Type of Device: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10012397
• MDR Text Key: 194486621
• Report Number: 8030965-2020-03208
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 007611819713666
• UDI-Public: (01)007611819713666
• Combination Product (y/n): N
• PMA/PMN Number: K031276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 450.152
• Device Lot Number: 2L27766
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2020
• Patient Sequence Number: 1
• Treatment: CERVSPINE-EXP-HEADSCR Ø4 SELF-DRILL L16; UNK - SCREWS: LOCKING; UNKNOWN CERVICAL SPINE EXPANSION HEAD SCREW
• Patient Outcome(s): Required Intervention