MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP TI POLY SCREW 9MMX45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712945
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The expedium 9x45mm ti polyaxial screw was not returned to the customer quality unit for evaluation.A review of the device history record (dhr) for the expedium 9x45mm ti polyaxial screw could not be performed as the lot number was not available.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the polyaxial screw we are unable to confirm the reported issue or identify the root cause.Device was not returned for evaluation, thus unable to confirm the reported issue.As such, the complaint will be closed with no further action.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 was reported that after removal of hardware, dr.(b)(6) attempted to replace a monarch bolt 8.5x15 with an expedium 9x45 (1796-12-945) poly screw.He did not tap as he did not believe it was necessary.During insertion, he encountered great resistance and the inner driver of the inserter broke off in the poly-screw.He then put a rod in the screw and attempted to helicopter the screw out, which failed as the poly head came apart under the stress.It was determined that leaving the remainder of the screw was best and the remainder of the case went off without incident.Attributable cause of the failure was documented by the sales rep as: prior surgery, very hard bone, and revision of a very large screw(an 8.5mm monarch bolt with a 9mm expedium poly screw.) the surgery was prolonged less than 30 minutes.No patient adverse consequence.

• Brand Name: EXP TI POLY SCREW 9MMX45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7579813
• Report Number: 1526439-2018-50536
• Device Sequence Number: 13948085
• Product Code: NKB
• UDI-Device Identifier: 10705034068244
• UDI-Public: (01)10705034068244
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: 179712945
• Device Catalogue Number: 179712945
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR