MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR LS SCREW 3.5X30; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188320330
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Visual examination of the mntr ls screw reveals signs of operative use as evidenced by superficial markings, with damage to the drive feature of the screw head and the inner cap (saddle) is dislodged and fell apart from its intended location.Exerting a significant amount of force on the tulip head and saddle, potentially at a significant angle, may be sufficient to dislodge the saddle.A dhr review did not identify any issues that could have cause or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the mntr ls screw falling apart cannot be determined from the sample and the information provided.A potential root cause may be excessive force inadvertently placed on the drive feature of the screw during tightening, potentially at a significant angle, resulting in the saddle falling apart during use.As no issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer, this complaint will be closed with no further action required.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
When the surgeon was doing final tightening with torque drivers the locking screw and the nut jumped out.Patient consequence?: no.

• Brand Name: MNTR LS SCREW 3.5X30
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7681339
• Report Number: 1526439-2018-50643
• Device Sequence Number: 16302237
• Product Code: NKG
• UDI-Device Identifier: 10705034158136
• UDI-Public: (01)10705034158136
• Combination Product (Y/N): N
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

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: 188320330
• Device Catalogue Number: 188320330
• Device Lot Number: ATFFG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1