MAUDE Adverse Event Report: SYNTHES ELMIRA VERTEBRAL SPACER-PR 8MMX22MM 13MM HEIGHT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 889.847

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Report was initially submitted on (b)(6) 2016.Advised by fda on august 14, 2020 to resubmit medwatch.Patient initials are (b)(6).Patient weight reported as (b)(6) kg.A device history record review was performed for the subject device lot.The review revealed no complaint related anomalies.The device history record shows this lot of 8mmx22mm vertebral spacer¿pr was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This order met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications at time of acceptance.No nonconforming reports were noted.The raw material met all dimensional and visual criteria at the time of release with no issues documented.The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It is reported during a posterior lumbar fusion procedure at l3-l4 and l4-l5, while surgeon was impacting the peek implant (vertebral spacer-pr) at l3-l4, the device shattered into approximately six (6) pieces.All the pieces were easily retrieved.Another peek implant was readily available and was used to complete the procedure successfully with no further harm to patient.The procedure was delayed approximately five (5) minutes due to this event.The patient reported to be doing well post-operatively.This is report 1 of 1 for (b)(4).

• Brand Name: VERTEBRAL SPACER-PR 8MMX22MM 13MM HEIGHT
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5673549
• MDR Text Key: 209193006
• Report Number: 3003506883-2016-10086
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 10705034800363
• UDI-Public: (01)10705034800363(10)H078674
• Combination Product (y/n): N
• PMA/PMN Number: K011037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 889.847
• Device Catalogue Number: 889.847
• Device Lot Number: H078674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 88 KG