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

Model Number	889.847
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3003506883-2016-10086
• Device Sequence Number: 3218690
• Product Code: MQP
• UDI-Device Identifier: 10705034800363
• UDI-Public: (01)10705034800363(10)H078674
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K011037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2016

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2016
• Supplement Date Received by Manufacturer: 05/09/2016
• Initial Report FDA Received Date: 05/23/2016
• Supplement Report FDA Received Date: 05/23/2016
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 88 KG